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Reusable Surgical Instrument
EUDAMEDFDA UDIClass I (EU MDR)
Ref 110045261Ref PLA-4521-TAPRef 110045273Ref BMA-4518-TAPRef 110045320
Identity
- Trade Name
- Reusable Surgical Instrument EUDAMEDGenie RCR Instruments FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDØ4.5 Reusable Taperad TAP FDA UDI
- Model / Reference
- 110045261 EUDAMEDPLA-4521-TAP EUDAMED110045273 EUDAMEDBMA-4518-TAP EUDAMEDFDA UDI110045320 EUDAMED
- Description
- Ø4.5 Reusable Taperad TAP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800071019404 EUDAMED08800071021193 EUDAMED08800071019527 EUDAMED08809595975517 EUDAMEDFDA UDI08800071019992 EUDAMED
- Basic UDI-DI
- B-08800071019404 EUDAMEDB-08800071021193 EUDAMEDB-08800071019527 EUDAMEDB-08809595975517 EUDAMEDB-08800071019992 EUDAMED
- FDA Product Code
- HWX FDA UDI
- EMDN Code
- L0927 ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE EUDAMEDL098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMEDL098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Reusable Surgical Instrument by OSTEONIC CO., Ltd. — Class I — 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-08800071019404 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSTEONIC Co., Ltd.
- EUDAMED SRN
- KR-MF-000008969
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (6)
- EUDAMED cf9a09a5-e7af-447a-9d92-670dec816283 61 fields · synced Aug 2, 2026
- EUDAMED 83e007da-c9d8-4cf4-83d7-27cab2e930ca 61 fields · synced May 18, 2026
- EUDAMED 6cedc7f7-58c3-4f43-b22b-a551fb4ecbe0 61 fields · synced May 18, 2026
- EUDAMED e558a0bf-6471-47a6-baed-2d013c639200 61 fields · synced May 19, 2026
- EUDAMED 62965179-3f23-4502-8625-a791c3734dd3 61 fields · synced May 19, 2026
- FDA UDI 18491ff6-44ad-4ea5-8025-99fb7f0eab4c 33 fields · synced May 30, 2026