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K-Wire Guide Ø2.0mm, Proximal Humerus
EUDAMEDFDA UDIClass I (EU MDR)
Ref A-2000
by Medartis AG
Identity
- Trade Name
- K-Wire Guide Ø2.0mm, Proximal Humerus EUDAMEDAPTUS FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Guides EUDAMEDK-Wire Guide Ø2.0mm, Proximal Humerus FDA UDI
- Model / Reference
- A-2000 EUDAMEDFDA UDI
- Description
- K-Wire Guide Ø2.0mm, Proximal Humerus FDA UDI
Identifiers
- Catalog Number
- A-2000 FDA UDI
- Primary DI / UDI-DI
- 07630894801839 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378007PE EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
K-Wire Guide Ø2.0mm, Proximal Humerus by Medartis AG — Class I — 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 | 76300378007PE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (2)
- EUDAMED 5720bd86-108a-4e27-9a86-26d8c008512b 61 fields · synced Jul 28, 2026
- FDA UDI 1e54b09a-f288-40f0-856b-75d0c3c9469a 34 fields · synced May 30, 2026