Identity
- Trade Name
- HI-LINE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- PS-Tools rotating instrument sterile RU EUDAMEDHI-LINE BARREL BURR II D7.0MM FDA UDI
- Model / Reference
- GD847R EUDAMEDFDA UDI
- Description
- HI-LINE BARREL BURR II D7.0MM FDA UDI
Identifiers
- Catalog Number
- GD847R FDA UDI
- Primary DI / UDI-DI
- 04038653279937 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000267132 EUDAMED
- FDA Product Code
- GEY FDA UDI
- EMDN Code
- Z12100980 INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hi-Line by Aesculap AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 403923900000267132 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 66b01a3d-576a-4691-ba25-538ba83c6909 61 fields · synced Jun 8, 2026
- FDA UDI 43f3b628-22ec-4ec1-926b-68b95ad7fd00 35 fields · synced May 30, 2026