Identity
- Trade Name
- HSEU FDA UDI
- Generic Name
- Gingival retraction solution FDA UDI
- Device Name
- 20% ferric sulfate gel used for immediate and profound control of bleeding. This gel works on both hard and soft tissue and is highly effective for the control of bleeding during impressions, restorations, and crown and bridge procedures. FDA UDI
- Model / Reference
- 5702545 FDA UDI
- Description
- 20% ferric sulfate gel used for immediate and profound control of bleeding. This gel works on both hard and soft tissue and is highly effective for the control of bleeding during impressions, restorations, and crown and bridge procedures. FDA UDI
Identifiers
- Catalog Number
- 5702545 FDA UDI
- Primary DI / UDI-DI
- 00304040151372 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gingival retraction solution
Hseu by Henry Schein, Inc. — 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
- Henry Schein, Inc.
Sources (1)
- FDA UDI a57af734-647d-47b3-8a09-7136624ecab0 35 fields · synced Jun 8, 2026