Identity
- Trade Name
- Epidri Pellets FDA UDI
- Generic Name
- Gingival retraction cord, medicated FDA UDI
- Device Name
- Hemostatic cotton pellets with epinephrine, approx. 350 pellets FDA UDI
- Model / Reference
- 12100 FDA UDI
- Description
- Hemostatic cotton pellets with epinephrine, approx. 350 pellets FDA UDI
Identifiers
- Catalog Number
- 12100 FDA UDI
- Primary DI / UDI-DI
- 00310866000770 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction cord, medicated FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Category: Gingival retraction cord, medicated
Epidri Pellets by Pascal Company, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, medicated.
- Expasyl — KERR CORPORATION · U
- Sure-endo — SURE DENT CORPORATION · U
- Expasyl — KERR CORPORATION · U
- Re-Cord™ Knitted Retraction Cord #3 — Den-Mat Holdings, LLC · Class I
- Sure-endo — SURE DENT CORPORATION · U
- Sure-endo — SURE DENT CORPORATION · U
- Re-Cord™ Knitted Retraction Cord #000 — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · U
- Sure-endo — SURE DENT CORPORATION · U
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pascal Company, Inc.
Sources (1)
- FDA UDI 1a20d096-f430-4269-a645-713e9e481893 36 fields · synced Jun 6, 2026