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GlenoTech®
EUDAMEDFDA UDIClass I (EU MDR)
Ref GLE9000426Ref GLE9000409Model Aiming deviceRef GLE9000407
by S.b.m. Sas
Identity
- Trade Name
- GlenoTech® EUDAMEDGlenoTech FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Glenoid instrumentation EUDAMEDGlenoTech® diamter 5 mm cannulated drill bit FDA UDI
- Model / Reference
- GLE9000426 EUDAMEDAiming device EUDAMEDGLE9000409 EUDAMEDGLE9000407 EUDAMEDØ 5 mm cannulated drill bit FDA UDI
- Description
- GlenoTech® diamter 5 mm cannulated drill bit FDA UDI
Identifiers
- Catalog Number
- GLE9000426 FDA UDI
- Primary DI / UDI-DI
- 03760304681059 EUDAMEDFDA UDI03760304681028 EUDAMED03760304681011 EUDAMED
- Basic UDI-DI
- 376015400DT2021012TV EUDAMED376015400DT2021011TT EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMEDL091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
GlenoTech® by S.b.m. Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 376015400DT2021012TV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.b.m. Sas
- EUDAMED SRN
- FR-MF-000000214
Sources (4)
- EUDAMED 5671518d-6f94-4b13-8e05-e43345ce7d3c 61 fields · synced Jul 30, 2026
- EUDAMED cc9d4054-d7cf-4ce5-bdad-a1f6f8ca5614 61 fields · synced May 17, 2026
- EUDAMED 4a1d9a40-3c92-4078-a1d5-33bd22cf3538 61 fields · synced May 18, 2026
- FDA UDI ef368fad-888e-4753-b0ae-79d72152b6e7 34 fields · synced May 30, 2026