Identity
- Trade Name
- In2Bones EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- PERCUTANEOUS BURRS EUDAMEDSHANNON BURR LG20 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDI
- Model / Reference
- G01 01512 EUDAMEDFDA UDI
- Description
- SHANNON BURR LG20 MM STERILE DIA 2.0 X LENGTH 75 MM FDA UDI
Identifiers
- Catalog Number
- G01 01512 FDA UDI
- Primary DI / UDI-DI
- 03760225715918 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225715918 EUDAMED
- FDA Product Code
- GFF FDA UDI
- EMDN Code
- P091301 ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE EUDAMED
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 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
In2Bones by In2Bones SAS — Class IIa — 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-03760225715918 | 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 (2)
- EUDAMED b4ead60e-bc78-4c4b-92d1-731a4e2ddc12 61 fields · synced May 30, 2026
- FDA UDI 976d4cd3-b5b1-48ca-80d2-109435b4c244 35 fields · synced May 30, 2026