Identity
- Trade Name
- Kirschner wire EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Kirschner wire EUDAMED10 KWIRES DIAM 1.0 MM LENGTH 100 MM 1 SHARP END FDA UDI
- Model / Reference
- K11 NS100 EUDAMEDFDA UDI
- Description
- 10 KWIRES DIAM 1.0 MM LENGTH 100 MM 1 SHARP END FDA UDI
Identifiers
- Catalog Number
- K11 NS100 FDA UDI
- Primary DI / UDI-DI
- 03760225712283 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225712283 EUDAMED
- 510(k) Number
- K153204 FDA UDI
- FDA Product Code
- HTY FDA UDIFZX FDA UDI
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES EUDAMED
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDIOuter Diameter — 1.0 Millimeter FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Kirschner wire by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
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- SMART TSF — Smith & Nephew, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225712283 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (2)
- EUDAMED 7ef666e1-9cf5-4319-93b5-3900cd67e2d3 61 fields · synced May 30, 2026
- FDA UDI 703ac323-372a-48a5-8943-07a2cc7548ea 37 fields · synced May 30, 2026