Identity
- Trade Name
- Shark Screw® drill EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- chirurgische Produkte (surgical Instruments) EUDAMEDDrill for Shark Screw 3.5 / cannulated / Ø2.85 mm FDA UDI
- Model / Reference
- SCDR35 EUDAMEDFDA UDI
- Description
- Drill for Shark Screw 3.5 / cannulated / Ø2.85 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120125220044 EUDAMEDFDA UDI
- Basic UDI-DI
- 9120125220034J EUDAMED
- Direct Marketing DI
- 09120125220044 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L090901 BONE CUTTERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Shark Screw® drill by surgebright GmbH — 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 | 9120125220034J | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- surgebright GmbH
- EUDAMED SRN
- AT-MF-000002664
Sources (2)
- EUDAMED ff98566b-6f4d-45e8-92d5-d1e87d42520c 61 fields · synced Jun 8, 2026
- FDA UDI 04cf60f5-9851-4023-94f7-5d214e73c8c4 33 fields · synced May 30, 2026