Identity
- Trade Name
- Vitrolife FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Vitrolife Ultrasound Transmission Gel FDA UDI
- Model / Reference
- 14213 FDA UDI
- Description
- Vitrolife Ultrasound Transmission Gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350025911205 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Vitrolife by NEXT Medical Products Company — 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
- NEXT Medical Products Company
Sources (1)
- FDA UDI c04e0624-fd1a-45f1-b5fc-1ea173a5d12e 34 fields · synced Jun 8, 2026