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In2Bones
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref G01 00991Ref G01 01451Ref P01 00051Ref G01 00941Ref G01 00942Ref G01 01452Ref G01 00962Ref G01 00951Ref G01 00031Ref P01 00061Ref P01 00101Ref G01 01661Ref G01 01671Ref G01 01511Ref G02 00011Ref G01 00971Ref G01 00981Ref G01 00982Ref P01 00091
by In2Bones SAS
Identity
- Trade Name
- In2Bones EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDIOrthopaedic bur, reusable FDA UDISurgical depth gauge, reusable FDA UDICannulated surgical drill bit, single-use FDA UDIFluted surgical drill bit, reusable FDA UDI
- Device Name
- PERCUTANEOUS BURRS EUDAMEDNEOFIT MTP PLATING SYSTEM EUDAMEDI.B.S®-C Compression and I.B.S®-N Neutralization osteosynthesis Instruments EUDAMEDInstruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDPACK 5 SHANNON BURRS LG15 MM STERILE DIA 3.1 X LENGTH 75 MM FDA UDIPACK 5 WEDGE BURRS LG12.75 MM STERILE DIA 3.9 X LENGTH 75 MM FDA UDIMETATARSAL REAMER DIAM 14 MM CANNULATED AO ATTACHMENT FDA UDIPACK 5 SHANNON BURRS LG8 MM STERILE DIA. 2.0 X LENGTH 75 MM FDA UDIMEASURER FROM 10 TO 60 MM FDA UDIPHALANGEAL REAMER DIAM 18 MM CANNULATED AO ATTACHMENT FDA UDIWEDGE BURR LG13 MM STERILE DIA 2.9 X LENGTH 75 MM FDA UDIPACK 5 SHANNON BURRS LG12 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDIPACK 5 SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDIREAMER 2IN1 DIAM 1.6 LG 10 MM AO STERILE CANNULATED LG65 MM FDA UDIPHALANGEAL REAMER DIAM 16 MM CANNULATED AO ATTACHMENT FDA UDIPACK 5 SHANNON BURRS LG15 MM STERILE DIA 4.1 X LENGTH 75 MM FDA UDIDEPTH GAUGE FROM 10 TO 60 MM FDA UDIWEDGE BURRS LG12.75 MM STERILE DIA 3.9 X LENGTH 75 MM FDA UDIPACK 5 WEDGE BURRS LG13 MM STERILE DIA 4.3 X LENGTH 75 MM FDA UDIMETATARSAL REAMER DIAM 16 MM CANNULATED AO ATTACHMENT FDA UDIDRILL 2IN1 DIAM 4.3/5.8 LG120 NO STERILE CANNULATED 2.0 MM FDA UDISHANNON BURR LG15 MM STERILE DIA 3.1 X LENGTH 75 MM FDA UDISHANNON BURR LG12 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDI
- Model / Reference
- G01 00991 EUDAMEDFDA UDIG01 01451 EUDAMEDFDA UDIP01 00051 EUDAMEDFDA UDIG01 00941 EUDAMEDFDA UDIG01 00942 EUDAMEDFDA UDIG01 01452 EUDAMEDFDA UDIG01 00962 EUDAMEDFDA UDIG01 00951 EUDAMEDFDA UDIG01 00031 EUDAMEDFDA UDIP01 00061 EUDAMEDFDA UDIP01 00101 EUDAMEDFDA UDIG01 01661 EUDAMEDFDA UDIG01 01671 EUDAMEDFDA UDIG01 01511 EUDAMEDFDA UDIG02 00011 EUDAMEDFDA UDIG01 00971 EUDAMEDFDA UDIG01 00981 EUDAMEDFDA UDIP01 00091 EUDAMEDFDA UDIG01 00982 EUDAMEDFDA UDI
- Description
- PACK 5 SHANNON BURRS LG15 MM STERILE DIA 3.1 X LENGTH 75 MM FDA UDIPACK 5 WEDGE BURRS LG12.75 MM STERILE DIA 3.9 X LENGTH 75 MM FDA UDIMETATARSAL REAMER DIAM 14 MM CANNULATED AO ATTACHMENT FDA UDIPACK 5 SHANNON BURRS LG8 MM STERILE DIA. 2.0 X LENGTH 75 MM FDA UDIMEASURER FROM 10 TO 60 MM FDA UDIPHALANGEAL REAMER DIAM 18 MM CANNULATED AO ATTACHMENT FDA UDIWEDGE BURR LG13 MM STERILE DIA 2.9 X LENGTH 75 MM FDA UDIPACK 5 SHANNON BURRS LG12 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDIPACK 5 SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDIREAMER 2IN1 DIAM 1.6 LG 10 MM AO STERILE CANNULATED LG65 MM FDA UDIPHALANGEAL REAMER DIAM 16 MM CANNULATED AO ATTACHMENT FDA UDIPACK 5 SHANNON BURRS LG15 MM STERILE DIA 4.1 X LENGTH 75 MM FDA UDIDEPTH GAUGE FROM 10 TO 60 MM FDA UDIWEDGE BURRS LG12.75 MM STERILE DIA 3.9 X LENGTH 75 MM FDA UDIPACK 5 WEDGE BURRS LG13 MM STERILE DIA 4.3 X LENGTH 75 MM FDA UDIMETATARSAL REAMER DIAM 16 MM CANNULATED AO ATTACHMENT FDA UDIDRILL 2IN1 DIAM 4.3/5.8 LG120 NO STERILE CANNULATED 2.0 MM FDA UDISHANNON BURR LG15 MM STERILE DIA 3.1 X LENGTH 75 MM FDA UDISHANNON BURR LG12 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDI
Identifiers
- Catalog Number
- G01 00981 FDA UDIG01 01451 FDA UDIP01 00051 FDA UDIG01 00951 FDA UDIG01 01661 FDA UDIP01 00101 FDA UDIG01 00962 FDA UDIG01 00941 FDA UDIG01 01511 FDA UDIG02 00011 FDA UDIP01 00091 FDA UDIG01 00991 FDA UDIG01 01671 FDA UDIG01 01452 FDA UDIG01 00971 FDA UDIP01 00061 FDA UDIG01 00031 FDA UDIG01 00982 FDA UDIG01 00942 FDA UDI
- Primary DI / UDI-DI
- 03760225712504 EUDAMEDFDA UDI03760225713884 EUDAMEDFDA UDI03760225712399 EUDAMEDFDA UDI03760225712450 EUDAMEDFDA UDI03760225713914 EUDAMEDFDA UDI03760225713983 EUDAMEDFDA UDI03760225713938 EUDAMEDFDA UDI03760225712467 EUDAMEDFDA UDI03760225713068 EUDAMEDFDA UDI03760225712405 EUDAMEDFDA UDI03760225712443 EUDAMEDFDA UDI03701337609610 EUDAMEDFDA UDI03701337609627 EUDAMEDFDA UDI03760225715901 EUDAMEDFDA UDI03760225714560 EUDAMEDFDA UDI03760225712481 EUDAMEDFDA UDI03760225712498 EUDAMEDFDA UDI03760225712436 EUDAMEDFDA UDI03760225713952 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225712504 EUDAMEDB-03760225713884 EUDAMEDB-03760225712399 EUDAMEDB-03760225712450 EUDAMEDB-03760225713914 EUDAMEDB-03760225713983 EUDAMEDB-03760225713938 EUDAMEDB-03760225712467 EUDAMEDB-03760225713068 EUDAMEDB-03760225712405 EUDAMEDB-03760225712443 EUDAMED3701337641026R EUDAMED37013376411776 EUDAMEDB-03760225715901 EUDAMEDB-03760225714560 EUDAMEDB-03760225712481 EUDAMEDB-03760225712498 EUDAMEDB-03760225713952 EUDAMEDB-03760225712436 EUDAMED
- FDA Product Code
- GFF FDA UDIHTO FDA UDIHTJ FDA UDIGFG FDA UDI
- EMDN Code
- P091301 ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE EUDAMEDL091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMEDP091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMED
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDIOrthopaedic bur, reusable FDA UDISurgical depth gauge, reusable FDA UDICannulated surgical drill bit, single-use FDA UDIFluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI888.4540 FDA UDI888.4300 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDINot in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDIFDA 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
EUDAMEDEUDAMED
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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
In2Bones by In2Bones SAS — Class IIa — 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-03760225712504 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03760225712504 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (53)
- EUDAMED 18ba384c-9145-429c-b0e7-f20b42bf416a 61 fields · synced Aug 4, 2026
- EUDAMED 6cdf3184-0dfe-4eaa-98af-4a0d154202f5 61 fields · synced May 16, 2026
- EUDAMED 9b577da5-0868-477a-833d-4c38c7588af4 61 fields · synced May 17, 2026
- EUDAMED f99fa851-511b-449a-886e-cc8079fd404f 61 fields · synced May 17, 2026
- EUDAMED 523a139e-1314-41a9-bf9a-eb0136ec6a60 61 fields · synced May 17, 2026
- EUDAMED f4666676-d2b7-49e7-8a58-be9bb983673f 61 fields · synced May 17, 2026
- EUDAMED d1754a90-271f-473b-9b8d-ad64a0a83f31 61 fields · synced May 17, 2026
- EUDAMED 9cd5977c-fcf9-4d12-8b66-1ed852aca917 61 fields · synced May 17, 2026
- EUDAMED fbda7c0e-deb1-41e9-9c48-097ad1e72111 61 fields · synced May 17, 2026
- EUDAMED 71fbedea-5b1b-44ba-adea-329e17edbb83 61 fields · synced May 18, 2026
- EUDAMED 095a2e47-2651-49d1-b23c-7d7c24359d4d 61 fields · synced May 18, 2026
- EUDAMED 9e2dc8bc-7d7d-4a80-a22d-6a81f547398d 61 fields · synced May 18, 2026
- EUDAMED 6417a6ce-4128-44a6-9d5b-9d90f61ac786 61 fields · synced May 18, 2026
- EUDAMED f12f2e3a-b559-442b-8c16-743fd7039779 61 fields · synced May 18, 2026
- EUDAMED 01fe9592-40ab-4bab-994f-49ba30f05a3e 61 fields · synced May 18, 2026
- EUDAMED bd0a5be3-c31f-47a0-a5d7-0618fc991279 61 fields · synced May 18, 2026
- FDA UDI 20b543d8-fe9a-44a3-ae35-a097d20b4ac5 35 fields · synced May 29, 2026
- FDA UDI 43dc6452-5ab0-451a-9ec3-12c5af9a3028 35 fields · synced May 30, 2026
- FDA UDI 41f1f715-c656-46d4-80ba-ca6d035a0dfb 36 fields · synced May 30, 2026
- FDA UDI 19f397a2-7712-4759-a8eb-6414b0745361 35 fields · synced May 30, 2026
- FDA UDI 16b40a18-5aea-47bc-8bad-32d2ace7066b 35 fields · synced May 30, 2026
- FDA UDI 4fc75602-d98c-4413-a643-c6f302d39fd1 36 fields · synced May 30, 2026
- FDA UDI 4ee89c9f-14ca-4944-8de0-aa0be1acb0c6 35 fields · synced May 30, 2026
- FDA UDI 77b84ce5-8ba4-48b0-a49d-ccf9fe3c3f9a 35 fields · synced May 30, 2026
- FDA UDI c2f70eb7-68a7-4e70-b2a7-9ba911d59217 35 fields · synced May 30, 2026
- FDA UDI a4f2decf-30ef-47e1-ac5b-d044e2b0ae61 35 fields · synced May 30, 2026
- FDA UDI d859f4f3-5200-421c-bb14-b455105b26f3 36 fields · synced May 30, 2026
- FDA UDI 32dc824e-ac4c-4464-a365-3b4cffd5c327 35 fields · synced May 30, 2026
- FDA UDI bab39ce8-3afb-4bd5-b3c7-64e5cce1c415 35 fields · synced May 30, 2026
- FDA UDI 5d0ec94d-37be-4972-81bf-1b084ac098a9 35 fields · synced May 30, 2026
- FDA UDI bf2b2310-4e9c-43f4-9004-65c8bb86c544 35 fields · synced May 30, 2026
- FDA UDI 41b0defe-fd2c-42d7-91c3-e3eba0a9c86e 36 fields · synced May 30, 2026
- FDA UDI 623fd897-76d9-4590-9017-553d09ceb1e3 35 fields · synced May 30, 2026
- FDA UDI bccaeca1-8f8c-497c-a2b7-f4a983531ffb 35 fields · synced May 30, 2026
- FDA UDI 9368cd97-773b-4ede-b70c-e6fc1a5d7d00 35 fields · synced May 30, 2026
- EUDAMED 51c5eaf5-b674-4b70-967a-1c483084e8b0 61 fields · synced Jul 8, 2026
- EUDAMED f60280f0-8276-4d6e-9ccc-49ff69f23ab6 61 fields · synced Jul 9, 2026
- EUDAMED ee6178de-c9e1-4b38-9ed6-fb8464b93291 61 fields · synced Jul 14, 2026
- EUDAMED dad2381c-225a-4226-9406-d3e79c5348e9 61 fields · synced Jul 15, 2026
- EUDAMED a29f2645-ca9e-4afe-b1df-bfcd7d84b806 61 fields · synced Jul 16, 2026
- EUDAMED d1ce414e-19bd-4dc3-ac21-16762a051564 61 fields · synced Jul 16, 2026
- EUDAMED 3f7ad76f-7b45-4922-ae13-ba38b3323a3d 61 fields · synced Jul 20, 2026
- EUDAMED 49cf2072-800b-4b7c-a9bd-6fda00e0a62b 61 fields · synced Jul 20, 2026
- EUDAMED 1f3d49e8-7136-4b9e-90b1-a3f494cdff13 61 fields · synced Jul 21, 2026
- EUDAMED 3be185dc-640b-4287-92d5-aed4d52e0fda 61 fields · synced Jul 23, 2026
- EUDAMED 1fbe7f77-165f-48c5-9782-13d0327a4468 61 fields · synced Jul 24, 2026
- EUDAMED ef4975ca-5baf-49c4-a3b1-cda4ddbd2657 61 fields · synced Jul 24, 2026
- EUDAMED b271fb75-9a60-4591-a05f-f48787090420 61 fields · synced Jul 24, 2026
- EUDAMED d61df137-72d7-45d1-85ea-1623dc8a11b6 61 fields · synced Jul 27, 2026
- EUDAMED 7c71ce3c-bf47-4c1b-81dc-88bef8997a95 61 fields · synced Jul 30, 2026
- EUDAMED 3fb6d225-9d2e-41f5-b016-cb40db81d29f 61 fields · synced Aug 2, 2026
- EUDAMED f4bcfa8e-55a0-4486-90be-a4376f7695b8 61 fields · synced Aug 3, 2026
- EUDAMED c581ef0d-94cb-45e2-b20d-cd28f7c05bf8 61 fields · synced Aug 4, 2026