Identity
- Trade Name
- Retrax Gel FS Pro Pack EUDAMEDEU Retrax Gel FS ProPack FDA UDI
- Generic Name
- Gingival retraction solution FDA UDI
- Device Name
- Retrax Gel FS EUDAMED25% ferric sulfate gel, 12 - 0.75g syringe; Green FDA UDI
- Model / Reference
- 16740 EUDAMEDFDA UDI
- Description
- 25% ferric sulfate gel, 12 - 0.75g syringe; Green FDA UDI
Identifiers
- Catalog Number
- 16740 FDA UDI
- Primary DI / UDI-DI
- 00310866002323 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108665004GR EUDAMED
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Gingival retraction solution FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 cord, non-medicated
Retrax Gel FS Pro Pack by Pascal Company, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- Smartcord 2 — EASTDENT Co., Ltd · Class I
- roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
- Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
- Mouth Prop — Huanghua Promisee Dental Co.Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03108665004GR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 82749a1a-9f65-4e40-9e5c-9c307123fb94 61 fields · synced Jul 23, 2026
- FDA UDI fa8043ca-f1c9-4a01-b6da-2557ae990e11 37 fields · synced May 30, 2026