Identity
- Trade Name
- Tissue Goo™ Hemostatic Gel 4-Pack FDA UDI
- Generic Name
- Gingival retraction solution FDA UDI
- Device Name
- Gingival Retraction Solution FDA UDI
- Model / Reference
- 641904 FDA UDI
- Description
- Gingival Retraction Solution FDA UDI
Identifiers
- Catalog Number
- 641904 FDA UDI
- Primary DI / UDI-DI
- 00359883005665 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction solution FDA UDI
Classification
- Device Class
- U 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
Dimensions & Sizes
- Size
- Total Volume — 12 Milliliter FDA UDI
Category: Gingival retraction solution
Tissue Goo™ Hemostatic Gel 4-Pack by Den-Mat Holdings, LLC — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI a0bc15b7-5bcd-47db-9dd4-835a59286e2f 37 fields · synced Jun 9, 2026