Identity
- Trade Name
- Voyantmark Assembly FDA UDI
- Generic Name
- Radiographic image marker, automatic FDA UDI
- Model / Reference
- 54243-13 FDA UDI
Identifiers
- Catalog Number
- 54243-13 FDA UDI
- Primary DI / UDI-DI
- 04056481001759 FDA UDI
- FDA Product Code
- JAC FDA UDI
- GMDN Term
- Radiographic image marker, automatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Voyantmark Assembly by Brainlab SE — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
Sources (1)
- FDA UDI 53554392-4d70-42ad-b984-08cb8021eaa6 35 fields · synced May 30, 2026