Identity
- Trade Name
- Reusable Surgical Instrument EUDAMEDGenie RCR Instruments FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDØ5.5 Reusable Taperad TAP FDA UDI
- Model / Reference
- BMA-5519-TAP EUDAMEDFDA UDI
- Description
- Ø5.5 Reusable Taperad TAP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809595975531 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809595975531 EUDAMED
- FDA Product Code
- HWX FDA UDI
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE 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-08809595975531 | 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 (2)
- EUDAMED eefd7e14-c27e-48f6-98a2-159b63fbf0f9 61 fields · synced Jul 15, 2026
- FDA UDI 02310193-8f7b-42dd-9b96-a9abc614928d 33 fields · synced May 30, 2026