← Back to catalogue
Duafit
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref A60 SP175Ref A06 10401Ref A60 SP176Ref A60 SP006Ref A60 SP005
by In2Bones SAS
Identity
- Trade Name
- DUAFIT EUDAMEDFDA UDI
- Generic Name
- Phalangeal joint arthrodesis implant FDA UDIOrthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- DUAFIT® Interphalangeal implants EUDAMEDNEOSYS SINGLE USE INTRUMENTS SET EUDAMEDDUAFIT PIP 17° PEEK STERILE SIZE 1L FDA UDIDUAFIT SET 17° & 10° & 0° SINGLE USE INSTRUMENTS FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 2L FDA UDIDUAFIT PIP 17° PEEK STERILE SIZE 2L FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 1L FDA UDI
- Model / Reference
- A60 SP175 EUDAMEDFDA UDIA06 10401 EUDAMEDFDA UDIA60 SP176 EUDAMEDFDA UDIA60 SP006 EUDAMEDFDA UDIA60 SP005 EUDAMEDFDA UDI
- Description
- DUAFIT PIP 17° PEEK STERILE SIZE 1L FDA UDIDUAFIT SET 17° & 10° & 0° SINGLE USE INSTRUMENTS FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 2L FDA UDIDUAFIT PIP 17° PEEK STERILE SIZE 2L FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 1L FDA UDI
Identifiers
- Catalog Number
- A60 SP175 FDA UDIA06 10401 FDA UDIA60 SP006 FDA UDIA60 SP176 FDA UDIA60 SP005 FDA UDI
- Primary DI / UDI-DI
- 03760225718742 EUDAMEDFDA UDI03760225712993 EUDAMEDFDA UDI03760225718759 EUDAMEDFDA UDI03701337603052 EUDAMEDFDA UDI03701337603045 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225718742 EUDAMEDB-03760225712993 EUDAMEDB-03760225718759 EUDAMEDB-03701337603052 EUDAMEDB-03701337603045 EUDAMED
- FDA Product Code
- HWC FDA UDIKDD FDA UDI
- EMDN Code
- P090603 FOOT PROSTHESES INTERPHALANGEAL COMPONENTS EUDAMED
- GMDN Term
- Phalangeal joint arthrodesis implant FDA UDIOrthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMEDClass II FDA UDIClass I FDA UDI
- Regulation Number
- 888.3040 FDA UDI878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDIEUDAMEDFDA 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
Yes
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Duafit by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-03760225718742 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (12)
- EUDAMED a325630a-1e32-4cee-ab1e-e8bcb22c27e9 61 fields · synced Jul 29, 2026
- EUDAMED a0f3d54a-f940-480f-bac2-f8100d48a2a4 61 fields · synced May 18, 2026
- EUDAMED e34fd7dc-3986-4d7a-af29-ae46a977eed2 61 fields · synced May 18, 2026
- FDA UDI 53b2c5b0-1c90-4581-9043-8beec9513d8f 36 fields · synced May 30, 2026
- FDA UDI 59ea9985-ef24-444b-bf7a-f980934c4bf8 35 fields · synced May 30, 2026
- FDA UDI 0d8f953c-9adc-4829-beb9-1da325d26fff 36 fields · synced May 30, 2026
- FDA UDI 8c3d2a00-6d0a-4135-9e2c-5520b05236ca 36 fields · synced May 30, 2026
- FDA UDI 1ee00282-8875-4436-9fb8-b7a52664ccb2 36 fields · synced May 30, 2026
- EUDAMED ea1e7fa9-1791-4ac2-afd8-bbfba5fbf918 61 fields · synced Jul 12, 2026
- EUDAMED db9e8a72-1057-470f-a996-cef605517433 61 fields · synced Jul 15, 2026
- EUDAMED bb4c7d65-fe30-4427-bf88-6385de47791e 61 fields · synced Jul 16, 2026
- EUDAMED fb756cc2-9420-495a-a1a4-86db085031f9 61 fields · synced Jul 29, 2026