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Anterior Hand Driver For Implant
EUDAMEDFDA UDIClass I (EU MDR)
Ref AHDIRef HAHD12EHRef HAHD09MSHRef ASD05SHRef HIHD20HRef HAHD12SHRef AHD09MSHRef IHD27HRef HAHD09LHRef AHD12MHRef ASD05LHRef IHD20HRef HAHDI
Identity
- Trade Name
- Anterior Hand Driver For Implant EUDAMEDFDA UDIHand Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- AHDI EUDAMEDFDA UDIHIHD20H EUDAMEDFDA UDIASD05LH EUDAMEDFDA UDIAHD09MSH EUDAMEDFDA UDIAHD12MH EUDAMEDFDA UDIIHD27H EUDAMEDFDA UDIHAHDI EUDAMEDFDA UDIHAHD09MSH EUDAMEDFDA UDIHAHD12SH EUDAMEDFDA UDIASD05SH EUDAMEDFDA UDIIHD20H EUDAMEDFDA UDIHAHD09LH EUDAMEDFDA UDIHAHD12EH EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000930268 EUDAMEDFDA UDI08800209368039 EUDAMEDFDA UDI08800209392935 EUDAMEDFDA UDI08800209392546 EUDAMEDFDA UDI08800209392577 EUDAMEDFDA UDI08809892357870 EUDAMEDFDA UDI08800209365779 EUDAMEDFDA UDI08800209365700 EUDAMEDFDA UDI08800209365762 EUDAMEDFDA UDI08800209392942 EUDAMEDFDA UDI08809892357863 EUDAMEDFDA UDI08800209365694 EUDAMEDFDA UDI08800209365724 EUDAMEDFDA 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
Anterior Hand Driver For Implant by Osstem Implant Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000406CLASSIBS25V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (26)
- EUDAMED 129c5a43-6b10-47bc-969c-6351a09ac799 61 fields · synced Aug 1, 2026
- FDA UDI f7ecd3ae-fda7-448e-a1e6-ccad2d5c5ce5 32 fields · synced May 29, 2026
- FDA UDI 8fa03635-3e73-4989-93fd-0b19666eb141 32 fields · synced May 29, 2026
- FDA UDI 5cb44ef3-6e74-452e-8449-842875683bdd 32 fields · synced May 29, 2026
- FDA UDI 9b9351db-3e1a-424b-9234-5654d52b1953 32 fields · synced May 29, 2026
- FDA UDI adb340a3-da71-4f10-a70b-b563860def3b 32 fields · synced May 29, 2026
- FDA UDI 65397bf3-997d-424c-adab-f02477c318b7 32 fields · synced May 30, 2026
- FDA UDI 7258c1ae-3464-4e5a-8943-078eea4322c3 32 fields · synced May 30, 2026
- FDA UDI 01a79dc9-f42f-476e-9788-13017d67ef96 32 fields · synced May 30, 2026
- FDA UDI 93fdf573-338c-4900-895e-3c713dbe725f 32 fields · synced May 30, 2026
- FDA UDI 32e29ffc-b13e-4a2a-9399-0ce0d6a03cea 32 fields · synced May 30, 2026
- FDA UDI 6ad1bebe-d690-4d5c-b125-1c7b696b66a4 32 fields · synced May 30, 2026
- FDA UDI b64d4013-0884-46f8-861b-02fcf4a636c4 32 fields · synced May 30, 2026
- FDA UDI 5ccf506f-6333-400b-bb4e-b4b14c696043 32 fields · synced May 30, 2026
- EUDAMED 077cd193-9094-435a-b453-0aaa70761f47 61 fields · synced Jun 20, 2026
- EUDAMED ac0466ca-0ff4-4e67-a39f-7fc376501920 61 fields · synced Jul 9, 2026
- EUDAMED 33eea823-0c25-4d76-9d28-73b1f8dfd93d 61 fields · synced Jul 9, 2026
- EUDAMED 8e72e711-5985-4f16-ada3-70032c0a4017 61 fields · synced Jul 11, 2026
- EUDAMED a492b85e-ee21-4a5e-b670-cc8f0821af41 61 fields · synced Jul 12, 2026
- EUDAMED 6dc508c0-213a-4bcd-872e-44bbfdd9fabe 61 fields · synced Jul 13, 2026
- EUDAMED 6554d0b7-82e8-442c-9448-f44f9b411821 61 fields · synced Jul 20, 2026
- EUDAMED 0e1e49e9-1e07-42fa-8ede-2d63cf257d43 61 fields · synced Jul 21, 2026
- EUDAMED e05ca6d4-948a-4f41-a224-d390d13854db 61 fields · synced Jul 24, 2026
- EUDAMED 351e89d7-df00-433b-99e4-e8e44b8645ae 61 fields · synced Jul 24, 2026
- EUDAMED b529d84b-78fa-4872-a78b-98130f1cdf38 61 fields · synced Jul 30, 2026
- EUDAMED 5f21b771-aed1-4876-b479-0961077b5ae8 61 fields · synced Aug 1, 2026