Identity
- Trade Name
- TELEGRAPH EVO DRILL TIP 2.5 GUIDE EUDAMEDDRILL TIP 2,5 GUIDE FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- TELEGRAPH EVOLUTION reusable instruments EUDAMED
- Model / Reference
- 253677 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489536779 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661489TELEVOCIRMM3 EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 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
No
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: Orthopaedic prosthesis implantation positioning instrument, reusable
Drill Tip 2, 5 Guide by Fournitures Hospitalieres Industrie — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K023241 also covers:
- AXE DE MASSELOTTE — FOURNITURES HOSPITALIERES INDUSTRIE
- CANULE COURTE — FOURNITURES HOSPITALIERES INDUSTRIE
- CONNECTING SCREW M5 — FOURNITURES HOSPITALIERES INDUSTRIE
- CONTAINER 550X265X125 — FOURNITURES HOSPITALIERES INDUSTRIE
- D5 M3, 5 MIXED CONNEXION SCREW — FOURNITURES HOSPITALIERES INDUSTRIE
- D7 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D8 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D9 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL LEFT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL RIGHT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- ECARTEUR DE CHAIR A ERGOT — FOURNITURES HOSPITALIERES INDUSTRIE
- ENSEMBLE POUTRE DE GUIDAGE 2 TROUS — FOURNITURES HOSPITALIERES INDUSTRIE
K033510 also covers:
- AXE DE MASSELOTTE — FOURNITURES HOSPITALIERES INDUSTRIE
- CANULE COURTE — FOURNITURES HOSPITALIERES INDUSTRIE
- CONTAINER 550X265X125 — FOURNITURES HOSPITALIERES INDUSTRIE
- D5 M3, 5 MIXED CONNEXION SCREW — FOURNITURES HOSPITALIERES INDUSTRIE
- D7 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D8 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D9 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL LEFT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL RIGHT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- ECARTEUR DE CHAIR A ERGOT — FOURNITURES HOSPITALIERES INDUSTRIE
- FORET A BUTEE D4.5 EMBOUT AO — FOURNITURES HOSPITALIERES INDUSTRIE
- GUIDE DE MASSELOTTE — FOURNITURES HOSPITALIERES INDUSTRIE
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fournitures Hospitalieres Industrie
Sources (2)
- FDA UDI fae19b84-67fc-49f3-bd7e-2b7963d1a8bc 33 fields · synced Aug 3, 2026
- EUDAMED 31a3ace1-3e3a-4bb7-aa5d-bd60c1ccff02 61 fields · synced Aug 3, 2026