FDA UDI
In Commercial Distribution
🇺🇸 United States
LANEX Medium Screens
DI: 60889971367433
·
Model: LANEX Medium Screens
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LANEX Medium Screens
- Primary DI
- 60889971367433
- Version / Model
- LANEX Medium Screens
- Catalog Number
- 1367432
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a723ea77-79c6-40a4-beec-5be5125fd991
Device Description
LANEX Medium SCR 1PR 15x30cm hinged
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EAM | Screen, intensifying, radiographic | Radiology | 892.1960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34317 | X-ray intensifying screen | A device typically considered to be a component of an x-ray film cassette used in diagnostic x-ray applications. It is typically used in pairs with double side emulsion x-ray film. It consists of a backing material, e.g., cardboard, plastic or metal; a reflecting layer of material, e.g., titanium dioxide; an active layer of light-emitting phosphor, e.g., calcium tungstate, barium sulfate, or rare earth material; and a protective layer, typically a plastic coating used to reduce static electricity and allow cleaning. It is used to reduce the x-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60889971367433 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius