Identity
- Trade Name
- COOK FDA UDI
- Generic Name
- IVF oocyte aspiration pump FDA UDI
- Model / Reference
- G51607 FDA UDI
Identifiers
- Catalog Number
- K-MAR-5200-US FDA UDI
- Primary DI / UDI-DI
- 00827002516076 FDA UDI
- FDA Product Code
- MQG FDA UDI
- GMDN Term
- IVF oocyte aspiration pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: IVF oocyte aspiration pump
Cook by William A. Cook Australia Pty. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as IVF oocyte aspiration pump.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class II
Cleared under the same submission
K160753 also covers:
K992070 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- William A. Cook Australia Pty. Ltd.
Sources (1)
- FDA UDI c8541174-3b33-4bfd-b658-695c8d1f9f16 36 fields · synced Jun 8, 2026