Organization name

CooperSurgical, Inc.

SRN

US-MF-000002607

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW001

  Caution: Do not resterilize. Re-use of product, or use of microbial contaminated or expired product may result in suboptimal conditions for oocytes, cleavage stage embryos and blastocysts. These conditions may result in the failure of embryo development or to implant potentially leading to a failed assisted reproductive procedure.
• CW009

  Caution: The product is for single use and not to be reused due to risk of contamination.
• CW007

  Do not use the product if: • Product packaging appears damaged or broken
• CW032

  Do not use the product if: • Expiry date has been exceeded.
• CW999

  The VitriFit™ is an open system which means that the oocytes and embryos are in direct contact with liquid nitrogen (LN2). CooperSurgical recommends that you use a container that is suitable for the LN2, and which can be sterilized. It is also recommended to change LN2 between patients to avoid the risk of contamination and to use LN2 which complies with pharmacopeia specifications. Note: Before loading specimens, verify integrity of VitriFit™ tip. Note: Flat surface provided on the VitriFit™ for recording patient information. Note: Specimen must be loaded on concave surface (Figure 1). Flat indicates concave side up. Note: To avoid injuries with LN2, wear protective gloves and safety goggles. Note: Maximum storage time in nitrogen has not been established and is unknown, and users are advised to take all necessary precautions to safeguard the samples and validate own storage time. Note: To avoid contamination CooperSurgical strongly recommends that product should be opened and used only with aseptic technique. Note: Please note the need for traceability of this product. In addition, national legal requirements for this field may exist in your country. Note: Only to be used in combination with other products intended for the same purpose. Note: Dispose of the product in accordance with local regulations for disposal of medical devices. Note: VitriFit™ facilitates the safe and effective cryopreservation and storage of oocytes and embryos.Clinical benefit is derived from oocytes, cleavage and blastocyst stage embryos being preserved and used in subsequent transfer cycles, so contributing to cumulative chances of clinical pregnancy per egg collection cycle. This also reduces risks to women associated with controlled ovarian stimulation and oocyte retrieval. Note: Any serious incident that has occurred in relation to the product should be reported to the manufacturer and the Competent Authority of the member state in which the user is established

Primary placement in Netherlands; available across 32 countries total.

Trade name

VitriFit™

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

20888937028786

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0888937TD044ZP

Reference / catalog number

42792001

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.coopersurgical.com/Ifu

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U08020401CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.