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Follicle Aspiration Set, Single Lumen, Luer with Tubing
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Follicle Aspiration Set, Single Lumen, Luer with Tubing FDA UDI
- Generic Name
- IVF oocyte aspiration needle, single-use FDA UDI
- Model / Reference
- 14123 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350025911229 FDA UDI
- 510(k) Number
- K991273 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
- Not 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
No
FDA UDI
Follicle Aspiration Set, Single Lumen, Luer with Tubing by Vitrolife Sweden AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 81a81639-ef39-4fd8-b53c-ba79dd9125fd 34 fields · synced May 30, 2026