Identity
- Trade Name
- Retrax Gel FS ProPack SAMPLE FDA UDI
- Generic Name
- Gingival retraction solution FDA UDI
- Device Name
- Topical hemostatic gel with 15.5% ferric sulfate, 12 - 0.75g syringes FDA UDI
- Model / Reference
- 88103 FDA UDI
- Description
- Topical hemostatic gel with 15.5% ferric sulfate, 12 - 0.75g syringes FDA UDI
Identifiers
- Catalog Number
- 88103 FDA UDI
- Primary DI / UDI-DI
- 00310866002385 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
- Weight — 0.75 Gram FDA UDI
Category: Gingival retraction solution
Retrax Gel FS ProPack SAMPLE by Pascal Company, Inc. — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction solution.
- ViscoStat Clear — ULTRADENT PRODUCTS, INC. · U
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class II
- HSEU — HENRY SCHEIN, INC. · U
- Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution — Dentsply International · U
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class II
- HSEU — HENRY SCHEIN, INC. · U
- ViscoStat Clear — ULTRADENT PRODUCTS, INC. · U
- FASTRACT — BENCO DENTAL SUPPLY CO. · U
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pascal Company, Inc.
Sources (2)
- FDA UDI a7e549fe-0fe3-4edf-ba31-74e44388b2c4 37 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 29, 2026