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Implant Driver
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref HSSRFDERef HSSRFDSRef HGSRFDLRef HSSRFDL
Identity
- Trade Name
- Implant Driver EUDAMEDFDA UDIFixture Driver FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- HSSRFDS EUDAMEDFDA UDIHSSRFDL EUDAMEDFDA UDIHGSRFDL EUDAMEDFDA UDIHSSRFDE EUDAMEDFDA UDIGSRFDL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209372739 EUDAMEDFDA UDI08800209372722 EUDAMEDFDA UDI08800209367681 EUDAMEDFDA UDI08800209372715 EUDAMEDFDA UDI08800209358856 FDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable 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 screwdriver, reusable
Implant Driver 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 screwdriver, reusable.
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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 (9)
- FDA UDI e9aab71f-842c-467a-b07c-77c1a06ae520 32 fields · synced Jul 29, 2026
- FDA UDI 977e05ac-51a7-4a73-90fe-b282a5dbf945 32 fields · synced May 29, 2026
- FDA UDI dab9bdff-de5b-405a-a434-99814163a3d6 32 fields · synced May 30, 2026
- FDA UDI 7188a34e-b53d-4534-a28a-ac481ecf27e3 32 fields · synced May 30, 2026
- FDA UDI fa729084-f555-490d-9a27-dec2a6738024 32 fields · synced May 30, 2026
- EUDAMED aae79827-24df-4a0b-82d0-8a5a627ea906 61 fields · synced Jul 9, 2026
- EUDAMED 5c7b0ec3-dade-44cf-b4ba-400a45d05b79 61 fields · synced Jul 11, 2026
- EUDAMED b9ad7fd5-56cc-4401-a1a2-abfdb9cabd40 61 fields · synced Jul 28, 2026
- EUDAMED 1d0965d3-8129-4289-84f7-acc6501a1e46 61 fields · synced Jul 29, 2026