Identity
- Trade Name
- Gafchromic™ FDA UDI
- Generic Name
- Medical x-ray film, non-screen FDA UDI
- Model / Reference
- EBT-XD DP-850 @20SH FDA UDI
Identifiers
- Catalog Number
- 972177 FDA UDI
- Primary DI / UDI-DI
- 00850000065758 FDA UDI
- FDA Product Code
- IWZ FDA UDI
- GMDN Term
- Medical x-ray film, non-screen FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1840 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
No
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
Category: Medical x-ray film, non-screen
Gafchromic™ by Ashland Specialty Ingredients, G.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical x-ray film, non-screen.
- DRYVIEW DVC Laser Imaging Film — CARESTREAM HEALTH, INC. · Class I
- DRYPRO SD-QM2 — Konica Minolta, Inc. · Class I
- DRYVIEW DVE Laser Imaging Film — CARESTREAM HEALTH, INC. · Class I
- DRYVIEW DVB Laser Imaging Film — CARESTREAM HEALTH, INC. · Class I
- DRYVIEW DVM+ Mammography Laser Imaging Film — CARESTREAM HEALTH, INC. · Class I
- Oncology EDR2 Film — CARESTREAM HEALTH, INC. · Class I
- DRYVIEW DVC Laser Imaging Film — CARESTREAM HEALTH, INC. · Class I
- X-OMAT 2 Dental Duplicating — CARESTREAM HEALTH, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ashland Specialty Ingredients, G.P.
Sources (1)
- FDA UDI c7fde21a-75cb-4b13-9ccf-ea7e58e2d3e2 33 fields · synced Jun 9, 2026