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Refl. Marker Disks (Single Use, 3 Pcs)
FDA UDIClass II (US FDA UDI)
by Brainlab SE
Identity
- Trade Name
- Refl. Marker Disks (Single Use, 3 Pcs) FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 55760-03 FDA UDI
Identifiers
- Catalog Number
- 55760-03 FDA UDI
- Primary DI / UDI-DI
- 04056481001582 FDA UDI
- 510(k) Number
- K070106 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Refl. Marker Disks (Single Use, 3 Pcs) by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K070106 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
Sources (1)
- FDA UDI e1c9bd79-3f92-4d85-bd14-1715e08e8ea5 36 fields · synced May 30, 2026