Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Dental x-ray film, non-screen FDA UDI
- Device Name
- DX-54 Vinyl Packet Size 0 FDA UDI
- Model / Reference
- 1125309 FDA UDI
- Description
- DX-54 Vinyl Packet Size 0 FDA UDI
Identifiers
- Catalog Number
- 1125309 FDA UDI
- Primary DI / UDI-DI
- 10304040040925 FDA UDI
- FDA Product Code
- IWZ FDA UDI
- GMDN Term
- Dental 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: Dental x-ray film, non-screen
Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental x-ray film, non-screen.
- INSIGHT — CARESTREAM HEALTH, INC. · Class I
- BUTTERFLY BARRIER FILM FSS-58 — Flow X-Ray Corp. · Class I
- D-Speed — CARESTREAM HEALTH, INC. · Class II
- FILM DSS-58 D ADULT SINGLE FILM BUTTERFLY PACKETS D SPEED — Flow X-Ray Corp. · Class I
- DV-57 ADULT TWIN VALUE PAK — Flow X-Ray Corp. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- BUTTERFLY BARRIER FILM FSS-54 — Flow X-Ray Corp. · Class I
- D-Speed — 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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 3ba4f1d9-2ccc-40d3-a801-7670bcf9e1cf 35 fields · synced Jun 8, 2026