Identity
- Trade Name
- Bone Tack Holder Protector EUDAMEDBone Tack Holder Proetctor FDA UDI
- Generic Name
- Surgical instrument protective cap FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OBTHP EUDAMEDFDA UDIHBTHP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209376157 EUDAMEDFDA UDI08800209375914 FDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument protective cap FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument protective cap
Bone Tack Holder Proetctor by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument protective cap.
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Plasdent — PLASDENT CORP. · Class II
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- FENTEX — FENTEX medical GmbH · Class I
- US Polishing Protector — OSSTEM IMPLANT Co., Ltd. · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (3)
- FDA UDI 3b7c90df-234c-4c0b-8d84-d6653f027a02 32 fields · synced Jul 11, 2026
- FDA UDI 9acf1648-90e7-4a61-9b73-60511e2cc66f 32 fields · synced May 30, 2026
- EUDAMED c38eb43d-3066-4290-bc4b-25f9fc9903a2 61 fields · synced Jul 11, 2026