Identity
- Trade Name
- IBS EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Beveled Screw Sterile Instruments, Active EUDAMEDIBS-BDia.1.4, 1.6, and2.0mm K-Wires for use w/Mica Jig, 2ea FDA UDI
- Model / Reference
- C01 S2001 EUDAMEDFDA UDI
- Description
- IBS-BDia.1.4, 1.6, and2.0mm K-Wires for use w/Mica Jig, 2ea FDA UDI
Identifiers
- Catalog Number
- C01 S2001 FDA UDI
- Primary DI / UDI-DI
- 00810021867670 EUDAMEDFDA UDI
- Basic UDI-DI
- 08101755028045 EUDAMED
- FDA Product Code
- KDD FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium 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
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
Category: Joint prosthesis implantation kit, single-use
Ibs by In2Bones, USA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 08101755028045 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
- EUDAMED SRN
- US-MF-000023092
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (2)
- EUDAMED cd106c46-0fe8-49c2-8e36-eb1f89a78abf 61 fields · synced May 30, 2026
- FDA UDI 22a870c6-d4bc-4e57-8a55-b6c546650c9b 35 fields · synced May 30, 2026