Identity
- Trade Name
- Follicle Aspiration Set Double Lumen FDA UDI
- Generic Name
- IVF oocyte aspiration needle, single-use FDA UDI
- Model / Reference
- 17102 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350025915067 FDA UDI
- 510(k) Number
- K161970 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
Follicle Aspiration Set Double Lumen by Vitrolife Sweden AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as IVF oocyte aspiration needle, single-use.
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class II
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD. · 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
- Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class II
- 16G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
Cleared under the same submission
K161970 also covers:
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Single Lumen — Vitrolife Sweden AB
- Follicle Aspiration Set Single Lumen — Vitrolife Sweden AB
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
- Vitrolife Sweden AB
Sources (1)
- FDA UDI e6e12e34-2434-438e-b0f8-e698632f0346 33 fields · synced May 30, 2026