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CoLS Bone Tap
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 250105Model TLS reusable instruments
Identity
- Trade Name
- TLS TAP EUDAMEDCoLS Bone Tap FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- TLS reusable instruments EUDAMED
- Model / Reference
- 250105 EUDAMEDFDA UDITLS reusable instruments EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661489501050 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661489LIGTLSCIRMJZ EUDAMED
- Direct Marketing DI
- 03661489501050 EUDAMED
- FDA Product Code
- MBI FDA UDIHWC FDA UDI
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 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
CoLS Bone Tap by Fournitures Hospitalieres Industrie — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K113591 also covers:
- Angulated awl — FOURNITURES HOSPITALIERES INDUSTRIE
- BROCHE 25CM 2, 4MM BOUT MECHE BOUT ROND (Teknomedical) — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- Cannulated reamer Diameter 4, 5 — FOURNITURES HOSPITALIERES INDUSTRIE
- Chopping block — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS 2.4mm guide pin Lg 250mm Soft/drill — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS ACL femoral point to point guide V2 — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS ACL tibial point to point guide V2 — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS Open Tendon Stripper — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS PCL femoral guide V5 — FOURNITURES HOSPITALIERES INDUSTRIE
K120740 also covers:
- Angulated awl — FOURNITURES HOSPITALIERES INDUSTRIE
- BROCHE 25CM 2, 4MM BOUT MECHE BOUT ROND (Teknomedical) — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- Cannulated reamer Diameter 4, 5 — FOURNITURES HOSPITALIERES INDUSTRIE
- Chopping block — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS 2.4mm guide pin Lg 250mm Soft/drill — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS ACL femoral point to point guide V2 — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS ACL tibial point to point guide V2 — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS Open Tendon Stripper — 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 1648ecf5-cd97-47fb-82e1-13c5c532beb3 33 fields · synced Jun 19, 2026
- EUDAMED bc2fc136-661d-40b3-8877-53e4432f4ad5 61 fields · synced Jun 19, 2026