Identity
- Trade Name
- Cranberry FDA UDI
- Generic Name
- Rubber dam, Hevea-latex FDA UDI
- Device Name
- Smart Dam Latex Unscented Premium Powder Free Detal Dam Sample Pack Medium 6" X 6" (152mm X 152mm) - Inner Pack FDA UDI
- Model / Reference
- CR8166_SP FDA UDI
- Description
- Smart Dam Latex Unscented Premium Powder Free Detal Dam Sample Pack Medium 6" X 6" (152mm X 152mm) - Inner Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817508022048 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Rubber dam, Hevea-latex FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rubber dam, Hevea-latex
Cranberry by Ascend Eagle Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HYGENIC — Coltene/Whaledent Inc. · Class I
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
- Ascend Eagle Incorporated
Sources (1)
- FDA UDI f16b1d3a-e722-41a7-8b92-6525e2fd987e 34 fields · synced May 31, 2026