Identity
- Trade Name
- OMNIFLEX™ FDA UDI
- Generic Name
- Polyether dental impression material FDA UDI
- Device Name
- OMNIFLEX™ 45mL catalyst FDA UDI
- Model / Reference
- 137311 FDA UDI
- Description
- OMNIFLEX™ 45mL catalyst FDA UDI
Identifiers
- Catalog Number
- 137311 FDA UDI
- Primary DI / UDI-DI
- D6581373111 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Polyether dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- 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
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: Polyether dental impression material
Omniflex™ by Gc America Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI 5cabe002-3539-47a1-9851-312a8bcd659a 36 fields · synced May 30, 2026