← Back to catalogue
Gauge BL Pointer, Sharp Tip Extended
FDA UDIEUDAMEDClass I (US FDA UDI)
by Brainlab AG
Identity
- Trade Name
- Gauge BL Pointer, Sharp Tip Extended FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 52780-10 FDA UDI
Identifiers
- Catalog Number
- 52780-10 FDA UDI
- Primary DI / UDI-DI
- 04056481002183 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 FDA UDI
- Commercial Distribution
- 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
Moist Heat or Steam Sterilization FDA UDI
Category: Robotic surgical navigation system
Gauge BL Pointer, Sharp Tip Extended by Brainlab AG — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical navigation system.
- TMINI™ Navigation Console — Think Surgical Inc. · Class II
- VELYS — Medos International Sàrl · Class II
- EXCELSIUS GPS — GLOBUS MEDICAL, INC. · Class II
- OMNIBotics — OMNIlife science, Inc. · Class II
- EXCELSIUSGPS — GLOBUS MEDICAL, INC. · Class II
- SI-LOK — GLOBUS MEDICAL, INC. · Class II
- EXCELSIUS GPS — GLOBUS MEDICAL, INC. · Class II
- EXCELSIUS GPS — GLOBUS MEDICAL, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| 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 AG
Sources (2)
- FDA UDI 3e84740f-c5bb-48dd-b7dc-524128a28bb2 34 fields · synced Jun 8, 2026
- EUDAMED 1 fields · synced May 29, 2026