Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- IVF oocyte aspiration needle, single-use FDA UDI
- Device Name
- Ovum Aspiration Needle, Double Lumen FDA UDI
- Model / Reference
- G55796 FDA UDI
- Description
- Ovum Aspiration Needle, Double Lumen FDA UDI
Identifiers
- Catalog Number
- K-OPSD-1735-A-L-US FDA UDI
- Primary DI / UDI-DI
- 00827002557963 FDA UDI
- 510(k) Number
- K983593 FDA UDI
- FDA Product Code
- MQE FDA UDI
- GMDN Term
- IVF oocyte aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: IVF oocyte aspiration needle, single-use
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 needle, single-use.
- Follicle Aspiration Set Single Lumen, Luer — Vitrolife Sweden AB · Class II
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB · Class II
- 16G Wallace Dual Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
- 17G Wallace Dual Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
- 18G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
- 16G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
- 16G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
- Rocket — Rocket Medical Plc
Cleared under the same submission
K983593 also covers:
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD.
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 0a00beee-00f7-4f3a-9003-575b39af3f5b 37 fields · synced May 30, 2026