Identity
- Trade Name
- Medical X-ray Cassette with Green 400 Screens FDA UDI
- Generic Name
- Medical x-ray film, screen FDA UDI
- Device Name
- 13X18CM MX CASS W/GREEN 400 SCREEN FDA UDI
- Model / Reference
- Medical X-ray Cassette with Green 400 Screens FDA UDI
- Description
- 13X18CM MX CASS W/GREEN 400 SCREEN FDA UDI
Identifiers
- Catalog Number
- 6807085 FDA UDI
- Primary DI / UDI-DI
- 40889976807084 FDA UDI
- 510(k) Number
- K896708 FDA UDI
- FDA Product Code
- IXA FDA UDI
- GMDN Term
- Medical x-ray film, screen FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1850 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical x-ray film, screenX-ray film cassette, automatic film changing
Medical X-ray Cassette with Green 400 Screens by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray film cassette, automatic film changing.
- Select Cassette with LANEX Fast Screens — CARESTREAM HEALTH, INC. · Class II
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC. · Class II
- Select Cassette with LANEX Medium Screens — CARESTREAM HEALTH, INC. · Class I
- Extraoral Cassette with EV Screens — CARESTREAM HEALTH, INC. · Class I
- MIN-R 2 Cassette with MIN-R Screen — CARESTREAM HEALTH, INC. · Class I
- Select Cassette with LANEX Medium Screens — CARESTREAM HEALTH, INC. · Class II
- MIN-R 2 Cassette with MIN-R 2000 Screen — CARESTREAM HEALTH, INC. · Class II
- Select Cassette with LANEX Regular Screens — CARESTREAM HEALTH, INC. · Class II
Cleared under the same submission
K896708 also covers:
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carestream Health, Inc.
Sources (1)
- FDA UDI b9b0c44c-4fb7-4733-8dc3-414d541f869f 35 fields · synced Jun 8, 2026