FDA UDI
In Commercial Distribution
🇺🇸 United States
Dornier MedTech
DI: 04049957000561
·
Model: UIMS
·
Dornier MedTech GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dornier MedTech
- Primary DI
- 04049957000561
- Version / Model
- UIMS
- Catalog Number
- K1029225
- Company Name
- Dornier MedTech GmbH
- Labeler DUNS
- 388104085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-13
- Public Version
- 2
- Public Version Date
- 2024-02-06
- Public Version Status
- Update
- Public Device Record Key
- 625feecf-d40b-459b-a076-cc7ffabba928
Device Description
UIMS Viewing Station SC Low Line
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 |
|---|---|---|---|---|
| NSX | Software, Transmission And Storage, Patient Data |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40821 | Basic diagnostic x-ray system operation software | Mainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a general-purpose x-ray system configuration. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used identify different operating system versions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049957000561 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P840008 | 069 |