Organization name

CooperSurgical, Inc.

SRN

US-MF-000002607

Manufacturer status

Active

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

• CW007

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

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

  Note: The 4-Well GPS® Dish is intended for use in ART procedures and designed to optimize conditions during in vitro handling and culture. Clinical benefit is derived from maintenance of a supportive environment for oocytes and embryos as shown by subsequent fertilization, embryo development and clinical pregnancy Note: To avoid contamination CooperSurgical strongly recommends that product should be opened and used only with aseptic technique.

Primary placement in Netherlands; available across 32 countries total.

Trade name

GPS DISHWARE

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.

00888937029048

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.

0888937TD0872C

Reference / catalog number

4GPS-010

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.

• U080206CULTURE PLATES 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.