FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Voyantmark Assembly
DI: 04056481001759
·
Model: 54243-13
·
Brainlab AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Voyantmark Assembly
- Primary DI
- 04056481001759
- Version / Model
- 54243-13
- Catalog Number
- 54243-13
- Company Name
- Brainlab AG
- Labeler DUNS
- 314482980
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- 53554392-4d70-42ad-b984-08cb8021eaa6
- Distribution End Date
- 2022-12-20
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | 892.1640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40806 | Radiographic image marker, automatic | A camera or image formatting unit that is a component of a diagnostic imaging system used to imprint identifying marks on: 1) photographic film or x-ray film (by exposure to visible light); or 2) digitally, on images created using various diagnostic imaging modalities [e.g., magnetic resonance imaging (MRI), x-ray or nuclear medicine]. Depending on the design of the marking system, it may be electronically or computer-controlled. Most frequently, it is used to imprint information on the images related to image acquisition parameters, patient identification, and to record anatomical information on individual images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056481001759 | GS1 |
Customer Contacts
- Phone
- +49899915680
- [email protected]