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Torque Driver For Torque Wrench
EUDAMEDFDA UDIClass I (EU MDR)
Ref TRSD05LRef TRHD12SRef TRHD12LRef HTIHD20LRef HTIHD27Ref HTRSD05LRef TRHD09LRef TIHD27Ref HTRHD12SRef HTIHD20SRef HTRHD12MSRef TIHD20LRef HTRHD12LRef HTRHD09SRef TRHD12ERef TRSD05ERef HTRHD12M
Identity
- Trade Name
- Torque Driver For Torque Wrench EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- TRSD05L EUDAMEDFDA UDIHTRHD12M EUDAMEDFDA UDITRHD12L EUDAMEDFDA UDIHTIHD20S EUDAMEDFDA UDITIHD27 EUDAMEDFDA UDITRHD09L EUDAMEDFDA UDITRHD12S EUDAMEDFDA UDITRHD12E EUDAMEDFDA UDIHTRHD12MS EUDAMEDFDA UDITIHD20L EUDAMEDFDA UDIHTIHD27 EUDAMEDFDA UDITRSD05E EUDAMEDFDA UDIHTIHD20L EUDAMEDFDA UDIHTRHD09S EUDAMEDFDA UDIHTRSD05L EUDAMEDFDA UDIHTRHD12S EUDAMEDFDA UDIHTRHD12L EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000956312 EUDAMEDFDA UDI08800209373859 EUDAMEDFDA UDI08809917072672 EUDAMEDFDA UDI08800209373149 EUDAMEDFDA UDI08809917071927 EUDAMEDFDA UDI08809917072634 EUDAMEDFDA UDI08809917072719 EUDAMEDFDA UDI08809917072658 EUDAMEDFDA UDI08800209373866 EUDAMEDFDA UDI08809917071897 EUDAMEDFDA UDI08800209373156 EUDAMEDFDA UDI08809917072740 EUDAMEDFDA UDI08800209373132 EUDAMEDFDA UDI08800209373811 EUDAMEDFDA UDI08800209373903 EUDAMEDFDA UDI08800209373873 EUDAMEDFDA UDI08800209373835 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
Torque Driver For Torque Wrench 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 (34)
- EUDAMED 000a47bc-5d78-4a74-b358-dd4f058bc45a 61 fields · synced Aug 1, 2026
- FDA UDI 57cfa2fc-cd8a-4eb3-a0dc-4ab2a1beea55 32 fields · synced May 29, 2026
- FDA UDI 4bab513e-9c1d-4533-9c20-4a72526d60c8 32 fields · synced May 29, 2026
- FDA UDI c3c7d999-3379-430b-b5ad-6233153d7fe1 32 fields · synced May 29, 2026
- FDA UDI f57d919c-48a1-4287-b129-c54f9b561a9a 32 fields · synced May 29, 2026
- FDA UDI 50280bdc-1cfa-457b-a6a4-d6b72d7fe7f9 32 fields · synced May 30, 2026
- FDA UDI 654e8227-5e26-4c71-9ca1-826fee97d144 32 fields · synced May 30, 2026
- FDA UDI 2e91f508-21ec-498f-a792-a81bd3184445 32 fields · synced May 30, 2026
- FDA UDI aaf30fcf-591c-431b-939a-3dcfc1f2fc13 32 fields · synced May 30, 2026
- FDA UDI c2a19281-63b3-4e77-b853-a200bd2c6ad0 32 fields · synced May 30, 2026
- FDA UDI 45566481-e624-4d88-9501-b61bc37b9286 32 fields · synced May 30, 2026
- FDA UDI 8e1b2ec9-9867-4827-814a-ee2292b11de9 32 fields · synced May 30, 2026
- FDA UDI f277982b-4ef9-4308-83fa-90ec67a7ed3f 32 fields · synced May 30, 2026
- FDA UDI 393dfb9e-26ad-4867-9882-6faad6906686 32 fields · synced May 30, 2026
- FDA UDI 6f17fd2f-dc28-4660-9663-1d9da6df02d4 32 fields · synced May 30, 2026
- FDA UDI 1bdc88d3-ac36-4adb-80d1-e85383d971e4 32 fields · synced May 30, 2026
- FDA UDI d6cbfdd4-7f96-49e6-aad1-68d98a18918b 32 fields · synced May 30, 2026
- FDA UDI 7be94e5e-2bac-4b48-aa98-9fc9cff01d44 32 fields · synced May 30, 2026
- EUDAMED 2d2cbe60-ecca-4d1f-bdda-2ec965abcebd 61 fields · synced Jun 20, 2026
- EUDAMED 25df042b-f758-42b1-8ade-8037bc2defcf 61 fields · synced Jun 20, 2026
- EUDAMED 92104b95-daf1-497c-b362-0c27495448e1 61 fields · synced Jul 8, 2026
- EUDAMED a2ac7764-5a75-4d72-a875-c07365ee6d62 61 fields · synced Jul 9, 2026
- EUDAMED aa0a3f38-ca26-41df-bdea-357ee84cdd4a 61 fields · synced Jul 10, 2026
- EUDAMED 2e1aaa90-0a1b-4cfd-ae54-90b03c56f9df 61 fields · synced Jul 12, 2026
- EUDAMED 206fc200-a92b-4242-ba07-3ec56023c2dd 61 fields · synced Jul 13, 2026
- EUDAMED 3e4cab40-2bcd-42ff-950c-de99afb60e79 61 fields · synced Jul 13, 2026
- EUDAMED 8a6cb7a4-1c66-4c82-b98a-34012736b845 61 fields · synced Jul 15, 2026
- EUDAMED c5f34dd6-4904-4bea-bdd6-cc9ad387144c 61 fields · synced Jul 15, 2026
- EUDAMED 8b875797-f5ec-49e3-90da-a5a2632c4dd5 61 fields · synced Jul 21, 2026
- EUDAMED 188afe55-d799-42bf-b561-0a5aabb64bac 61 fields · synced Jul 21, 2026
- EUDAMED 19a56e64-f2b0-4fe4-b92f-8695bd2d1a78 61 fields · synced Jul 21, 2026
- EUDAMED ed2ee9b4-1259-4650-bac0-cbaddbf4f7b7 61 fields · synced Jul 28, 2026
- EUDAMED d1f5d55c-70af-4b0a-a503-3d4de0e7d2fd 61 fields · synced Jul 28, 2026
- EUDAMED a067cd10-a765-4349-8508-5eb892434868 61 fields · synced Aug 1, 2026