FDA UDI
In Commercial Distribution
🇺🇸 United States
Green RE 400 Speed
DI: 05414904040126
·
Model: Green RE 400 Speed 18X43
·
AGFA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Green RE 400 Speed
- Primary DI
- 05414904040126
- Version / Model
- Green RE 400 Speed 18X43
- Catalog Number
- EHYK8
- Company Name
- AGFA
- Labeler DUNS
- 374444883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2019-06-14
- Public Version Status
- Update
- Public Device Record Key
- 32727746-9c72-4dea-987c-783396ea5d3c
Device Description
USABS CAS US GREEN 400 18X43
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IXA | Cassette, radiographic film | Radiology | 892.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35437 | X-ray film cassette, manual | A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414904040126 | GS1 |
Customer Contacts
- Phone
- +1(877)777-2432
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023020 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 43 | Centimeter | |
| Length | 18 | Centimeter |