Identity
- Trade Name
- RACEGEL FDA UDI
- Generic Name
- Gingival retraction kit FDA UDI
- Device Name
- Thermo-gelifiable gel for gingival preparation FDA UDI
- Model / Reference
- 01C0500 FDA UDI
- Description
- Thermo-gelifiable gel for gingival preparation FDA UDI
Identifiers
- Catalog Number
- 01C0500 FDA UDI
- Primary DI / UDI-DI
- 03760140703359 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction kit FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Weight — 1.4 Gram FDA UDI
Racegel by Septodont Sas Specialites Septodont — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Septodont Sas Specialites Septodont
Sources (1)
- FDA UDI 87abdf9f-668b-4502-a9a4-d1d7a88ab082 37 fields · synced May 30, 2026