Identity
- Trade Name
- Centurion FDA UDI
- Generic Name
- Vaginal applicator, single-use FDA UDI
- Device Name
- APPLICATOR; VAGINAL, 10FR, 8 1/2', STER. FDA UDI
- Model / Reference
- 10FRGEL8 FDA UDI
- Description
- APPLICATOR; VAGINAL, 10FR, 8 1/2', STER. FDA UDI
Identifiers
- Catalog Number
- 10FRGEL8 FDA UDI
- Primary DI / UDI-DI
- 10653160243342 FDA UDI
- FDA Product Code
- HGD FDA UDI
- GMDN Term
- Vaginal applicator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal applicator, single-use
Centurion by Centurion Medical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Centurion Medical Products
Sources (1)
- FDA UDI cecc70cb-c49e-4b6e-8dd2-5f2c9b5bee8e 35 fields · synced Jun 1, 2026