FDA UDI
In Commercial Distribution
🇺🇸 United States
DR 100s
DI: 05414904271032
·
Model: 6013/100
·
AGFA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DR 100s
- Primary DI
- 05414904271032
- Version / Model
- 6013/100
- Catalog Number
- MAC3H
- Company Name
- AGFA
- Labeler DUNS
- 374444883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-14
- Public Version
- 2
- Public Version Date
- 2023-07-18
- Public Version Status
- Update
- Public Device Record Key
- bda8c395-395e-4648-8efc-12c80f2dd3bb
Device Description
Mobile DR
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IZL | System, x-ray, mobile | Radiology | 892.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37647 | Mobile basic diagnostic x-ray system, digital | An assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414904271032 | GS1 |
Customer Contacts
- Phone
- +1(877)777-2432
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191884 | 000 |