Identity
- Trade Name
- IBS-B EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Non-patient-contacting Class I instruments, Non-Active EUDAMEDIBS-B Guide - MIS Targeting guide tray base and lid assembly FDA UDI
- Model / Reference
- G01 404A00 EUDAMEDFDA UDI
- Description
- IBS-B Guide - MIS Targeting guide tray base and lid assembly FDA UDI
Identifiers
- Catalog Number
- G01 404A00 FDA UDI
- Primary DI / UDI-DI
- 00810021868110 EUDAMEDFDA UDI
- Basic UDI-DI
- 08101755028147 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- V0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument/implant rack
Ibs-B by In2Bones, USA — Class I — 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 | 08101755028147 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 eff7c01e-54b5-4e03-86e7-9b102e095d87 61 fields · synced May 30, 2026
- FDA UDI cd96dd7f-74c9-435a-b09c-23c3d361fd67 35 fields · synced May 30, 2026