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DuaFit®
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref A60 SP174Ref A60 SP002Ref A06 00061Ref A06 00101Ref A60 SP003Ref A60 SP104Ref A60 SP173Ref A60 SP103Ref A06 10021Model A06 10011Ref A60 SP102
by In2Bones SAS
Identity
- Trade Name
- DuaFit® EUDAMEDFDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDIPhalangeal joint arthrodesis implant FDA UDIInstrument tray, reusable FDA UDISurgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- DUAFIT® Interphalangeal implants EUDAMEDInstruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDDUAFIT CANAL SHAPER DISTAL P2 FDA UDIDUAFIT PIP 10° PEEK STERILE SIZE 4 FDA UDIDUAFIT PIP 10° PEEK STERILE SIZE 2 FDA UDIDUAFIT PIP 10° PEEK STERILE SIZE 3 FDA UDIDUAFIT BASE FDA UDIDUAFIT IMPLANT HOLDER 0° FDA UDIDUAFIT PIP 17° PEEK STERILE SIZE 4 FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 2 FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 3 FDA UDIDUAFIT PIP 17° PEEK STERILE SIZE 3 FDA UDI
- Model / Reference
- A60 SP174 EUDAMEDFDA UDIA60 SP002 EUDAMEDFDA UDIA06 00061 EUDAMEDFDA UDIA06 00101 EUDAMEDFDA UDIA60 SP003 EUDAMEDFDA UDIA60 SP104 EUDAMEDFDA UDIA60 SP173 EUDAMEDFDA UDIA60 SP103 EUDAMEDFDA UDIA60 SP102 EUDAMEDFDA UDIA06 10021 EUDAMEDFDA UDIA06 10011 EUDAMED
- Description
- DUAFIT CANAL SHAPER DISTAL P2 FDA UDIDUAFIT PIP 10° PEEK STERILE SIZE 4 FDA UDIDUAFIT PIP 10° PEEK STERILE SIZE 2 FDA UDIDUAFIT PIP 10° PEEK STERILE SIZE 3 FDA UDIDUAFIT BASE FDA UDIDUAFIT IMPLANT HOLDER 0° FDA UDIDUAFIT PIP 17° PEEK STERILE SIZE 4 FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 2 FDA UDIDUAFIT PIP 0° PEEK STERILE SIZE 3 FDA UDIDUAFIT PIP 17° PEEK STERILE SIZE 3 FDA UDI
Identifiers
- Catalog Number
- A06 00061 FDA UDIA60 SP104 FDA UDIA60 SP102 FDA UDIA60 SP103 FDA UDIA06 10021 FDA UDIA06 00101 FDA UDIA60 SP174 FDA UDIA60 SP002 FDA UDIA60 SP003 FDA UDIA60 SP173 FDA UDI
- Primary DI / UDI-DI
- 03760225710470 EUDAMEDFDA UDI03760225712207 EUDAMEDFDA UDI03760225715802 EUDAMEDFDA UDI03760225715840 EUDAMEDFDA UDI03760225712023 EUDAMEDFDA UDI03760225710432 EUDAMEDFDA UDI03760225710463 EUDAMEDFDA UDI03760225710425 EUDAMEDFDA UDI03760225710418 EUDAMEDFDA UDI03760225710906 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225710470 EUDAMEDB-03760225712207 EUDAMED3701337641016P EUDAMED3701337641006M EUDAMEDB-03760225712023 EUDAMEDB-03760225710432 EUDAMEDB-03760225710463 EUDAMEDB-03760225710425 EUDAMED3701337640927F EUDAMEDB-03760225710418 EUDAMED
- Direct Marketing DI
- 03760225710906 EUDAMED
- 510(k) Number
- K132912 FDA UDI
- FDA Product Code
- HWJ FDA UDIHWC FDA UDIFSM FDA UDIHWR FDA UDI
- EMDN Code
- P090603 FOOT PROSTHESES INTERPHALANGEAL COMPONENTS EUDAMEDL091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDIPhalangeal joint arthrodesis implant FDA UDIInstrument tray, reusable FDA UDISurgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 888.4540 FDA UDI888.3040 FDA UDI878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
No
EUDAMEDEUDAMED
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 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
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Millimeter FDA UDIAngle — 10 degree FDA UDILength — 14 Millimeter FDA UDILength — 17 Millimeter FDA UDIAngle — 17 degree FDA UDI
DuaFit® by In2Bones SAS — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-03760225710470 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-03760225710470 | 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 (27)
- EUDAMED 57b47d3c-3919-4121-a2eb-4e63777ab7f1 61 fields · synced Jul 30, 2026
- EUDAMED 1d444753-bb9b-469a-8c40-2db19201dc95 61 fields · synced May 17, 2026
- EUDAMED e8daecdb-3ff0-4df9-96a4-df476fe2721a 61 fields · synced May 17, 2026
- EUDAMED cb919250-739d-4b42-b040-e0e0bf7d6bf2 61 fields · synced May 18, 2026
- EUDAMED b00979b1-7447-4f72-a57e-38d3c12aca48 61 fields · synced May 18, 2026
- EUDAMED e46d796c-492a-476b-a4c5-d7cfff1b5586 61 fields · synced May 18, 2026
- EUDAMED 4f81248e-6712-4d41-bb31-f0ca6c2aaaf0 61 fields · synced May 18, 2026
- EUDAMED b85e7fa6-20a3-4fad-a9d8-4ac7798193ee 61 fields · synced May 18, 2026
- FDA UDI fded0716-6af5-429b-a305-d2cce94d02d6 35 fields · synced May 30, 2026
- FDA UDI 23e97dc9-4122-45d0-979c-fe23f22f5894 37 fields · synced May 30, 2026
- FDA UDI 667ba603-faa3-447d-b0d9-bc166e2b431a 37 fields · synced May 30, 2026
- FDA UDI 0775da2b-3853-4ebe-b379-17c0fa54a35f 37 fields · synced May 30, 2026
- FDA UDI 77d731e7-8a7c-40c9-942c-f01eba8f09db 35 fields · synced May 30, 2026
- FDA UDI 97fd8496-ef90-4215-be2b-d2c4f93d2045 35 fields · synced May 30, 2026
- FDA UDI 5c3731b5-e7f5-4bef-aefb-7441bef38ad2 37 fields · synced May 30, 2026
- FDA UDI a9fcae78-39ee-49bb-a20d-027e8738300c 37 fields · synced May 30, 2026
- FDA UDI 3268a377-7dac-4413-a414-14e211761929 37 fields · synced May 30, 2026
- FDA UDI 037a8882-2e4d-43a7-b369-8bb316d5f2eb 37 fields · synced May 30, 2026
- EUDAMED bda87517-7a38-4beb-8a47-7d61478e868e 61 fields · synced Jul 11, 2026
- EUDAMED dbd76197-9679-45bc-b1d7-9d3dfcff7595 61 fields · synced Jul 11, 2026
- EUDAMED 95955d88-3d9d-49aa-9d2a-2d09f810e838 61 fields · synced Jul 14, 2026
- EUDAMED 778687e2-a332-4792-a652-3fe4172d80e8 61 fields · synced Jul 14, 2026
- EUDAMED a1d08066-2eca-4262-9a1e-0069792c79a1 61 fields · synced Jul 24, 2026
- EUDAMED 79df7e47-7184-43d4-9b4b-ddd3e30fa188 61 fields · synced Jul 25, 2026
- EUDAMED 5efaaeee-382b-42d5-9c53-434394bae6a3 61 fields · synced Jul 26, 2026
- EUDAMED 106e5899-3214-488c-88ec-66bd6dc9b2b2 61 fields · synced Jul 30, 2026
- EUDAMED 050cb121-14e8-4e2e-849d-15a99dd200d8 61 fields · synced Jul 30, 2026