Identity
- Trade Name
- Select Cassette with LANEX Regular Screens FDA UDI
- Generic Name
- X-ray intensifying screen FDA UDI
- Device Name
- 30X35CM SLCT CASS W/LANX REG C1 FDA UDI
- Model / Reference
- Select Cassette with LANEX Regular Screens FDA UDI
- Description
- 30X35CM SLCT CASS W/LANX REG C1 FDA UDI
Identifiers
- Catalog Number
- 1005032 FDA UDI
- Primary DI / UDI-DI
- 60889971005038 FDA UDI
- FDA Product Code
- IXA FDA UDIEAM FDA UDI
- GMDN Term
- X-ray intensifying screen FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1850 FDA UDI892.1960 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: X-ray intensifying screenX-ray film cassette, automatic film changing
Select Cassette with LANEX Regular 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
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 |
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Manufacturer
- Manufacturer
- Carestream Health, Inc.
Sources (1)
- FDA UDI cadc4232-5119-4ef4-84b5-1dd5b45ddd21 34 fields · synced Jun 8, 2026