Identity
- Trade Name
- HI-LINE XS EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- PS-Tools rotating instrument sterile SU EUDAMEDHI-LINE XS DISP.TC NEURO CUTTER III D3.1 FDA UDI
- Model / Reference
- GE635TC-SU EUDAMEDFDA UDI
- Description
- HI-LINE XS DISP.TC NEURO CUTTER III D3.1 FDA UDI
Identifiers
- Catalog Number
- GE635TC-SU FDA UDI
- Primary DI / UDI-DI
- 04046963187095 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000026753A EUDAMED
- FDA Product Code
- GEY FDA UDI
- EMDN Code
- Z12100980 INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic bur, single-use 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
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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 Xs 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 | 40392390000026753A | 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 052c7e1e-9850-4b93-b752-b0080eaa9746 61 fields · synced Jul 9, 2026
- FDA UDI 3695d295-467d-4465-9bd9-640553007425 35 fields · synced May 30, 2026