Organization name

CooperSurgical, Inc.

SRN

US-MF-000002607

Manufacturer status

Active

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

• Contains human blood or plasma derivatives

  This product contains: • Human serum albumin (HSA) 5 mg/mL. Note: This product contains human serum albumin (HSA), a derivative of human blood. Caution: All blood products should be treated as potentially infectious. The source material used to manufacture this product is fulfilling all regulatory requirements (Ph.Eur., USP), including screening of plasma donors for prior exposure to certain viruses, testing for presence of certain current virus infections (e.g., hepatitis, HIV, and parvovirus), and inactivating certain viruses by pasteurization. No known test methods can offer assurances that products derived from human blood will not transmit infectious agents. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is considered extremely remote, with no cases of transmission of viral diseases or CJD ever identified for human serum albumin.

• Do not use if package is damaged

  Do not use the product if: • Product packaging appears damaged or if the seal is broken. • The product becomes discoloured, cloudy, turbid, or shows any evidence of microbial contamination.

• Do not use past indicated date

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

• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  Caution: This product contains the antibiotic gentamicin sulphate. Do not use for individuals with known allergy to gentamicin or similar antibiotics.

• P235 – Keep cool.

  Store in original container at 2-8°C, protected from light.

• Note: To avoid contamination CooperSurgical strongly recommends that product/bottle 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: 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.

  OTHER

• Contains biological material of animal origin

  This product contains: • Gentamicin sulphate 10 μg/mL.

• Contains a medicinal substance

  This product contains: • Human serum albumin (HSA) 5 mg/mL. • Recombinant human insulin • Gentamicin sulphate 10 μg/mL.

Primary placement in Netherlands; available across 32 countries total.

Trade name

Sperm Preparation Medium

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.

60888937029286

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.

0888937TD09429

Reference / catalog number

10701010

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 III

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.

• U08020502MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.