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Remover Body
EUDAMEDFDA UDIClass I (EU MDR)
Ref FRBR40SRef FRKRBE50SRef HFRBW50SRef FRKRBE70SRef FRKRBE70LRef HFRBUW60SRef FRBW50LRef HFRBUW60LRef FRBM35LRef FRKRBILRef HFRBM35SRef FRBM35SRef FRBW50SRef FRBUW60SRef HFRBW57SRef HFRBR40LRef FRBW57LRef FRKRBE50L
Identity
- Trade Name
- Remover Body EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- FRBR40S EUDAMEDFDA UDIFRBUW60S EUDAMEDFDA UDIFRBM35L EUDAMEDFDA UDIFRBW50S EUDAMEDFDA UDIHFRBW50S EUDAMEDFDA UDIHFRBM35S EUDAMEDFDA UDIHFRBUW60L EUDAMEDFDA UDIFRKRBE50S EUDAMEDFDA UDIFRKRBE50L EUDAMEDFDA UDIFRBW50L EUDAMEDFDA UDIFRBW57L EUDAMEDFDA UDIHFRBR40L EUDAMEDFDA UDIHFRBUW60S EUDAMEDFDA UDIFRKRBE70L EUDAMEDFDA UDIHFRBW57S EUDAMEDFDA UDIFRKRBE70S EUDAMEDFDA UDIFRBM35S EUDAMEDFDA UDIFRKRBIL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000958088 EUDAMEDFDA UDI08800209393765 EUDAMEDFDA UDI08800209393710 EUDAMEDFDA UDI08800209393789 EUDAMEDFDA UDI08800209366721 EUDAMEDFDA UDI08800209366660 EUDAMEDFDA UDI08800209366691 EUDAMEDFDA UDI08800209393925 EUDAMEDFDA UDI08800209393918 EUDAMEDFDA UDI08800209393772 EUDAMEDFDA UDI08800209393796 EUDAMEDFDA UDI08800209366677 EUDAMEDFDA UDI08800209366707 EUDAMEDFDA UDI08800209393932 EUDAMEDFDA UDI08800209366745 EUDAMEDFDA UDI08800209393949 EUDAMEDFDA UDI08800209393727 EUDAMEDFDA UDI08800209393956 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, single-use 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
Yes
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
Remover Body 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 (36)
- EUDAMED 91056424-1a1b-43b6-9d51-744fb8ffa78f 61 fields · synced Aug 3, 2026
- FDA UDI 3f5a3825-59d3-4b95-ab1f-bb7a3370186a 32 fields · synced May 30, 2026
- FDA UDI b34dad22-dfb4-4697-8dc9-f4dbcf64b2d8 32 fields · synced May 30, 2026
- FDA UDI ce076528-cafa-40a9-a7a3-053286e9640f 32 fields · synced May 30, 2026
- FDA UDI 6cd974f1-e681-4664-aed2-1b331a7ae8c7 32 fields · synced May 30, 2026
- FDA UDI 9c223333-8eec-46d0-9ded-389a2e8e9a04 32 fields · synced May 30, 2026
- FDA UDI 0558a6f9-fbbb-424c-9945-e77cde66185e 32 fields · synced May 30, 2026
- FDA UDI 93ffeb44-ed9b-4e28-a7dc-597df1f85ac9 32 fields · synced May 30, 2026
- FDA UDI 7e978acc-16a9-4bc6-bbfb-86ef836b13a4 32 fields · synced May 30, 2026
- FDA UDI 99c897a8-ce3c-4cba-8f11-92358ebba023 32 fields · synced May 30, 2026
- FDA UDI 72530c49-1dba-4f17-9eea-d67dbbae5f16 32 fields · synced May 30, 2026
- FDA UDI e89807f5-92d8-4d99-a43e-65f11fbaaa25 32 fields · synced May 30, 2026
- FDA UDI 5cffc40a-ebc8-40fb-afff-9d2dc04f9cac 32 fields · synced May 30, 2026
- FDA UDI c5b95cc9-1e47-45dd-8fd7-694438f1af05 32 fields · synced May 30, 2026
- FDA UDI 5bcfaf16-4ff2-4069-bfc3-6610a9220b5b 32 fields · synced May 30, 2026
- FDA UDI 466118fd-177c-4b8c-aa43-6e65dd90a95b 32 fields · synced May 30, 2026
- FDA UDI ddca9bd6-7b85-46c1-9bd9-8f3717c9574e 32 fields · synced May 30, 2026
- FDA UDI c22df723-fd2b-4ccd-ba35-1c58ba5d870c 32 fields · synced May 30, 2026
- FDA UDI 7af48350-13d5-46cb-9f72-91d1e414b23e 32 fields · synced May 30, 2026
- EUDAMED b44f1920-e475-4627-8014-998d97bb3686 61 fields · synced Jul 10, 2026
- EUDAMED cf6bdc93-f53e-47ba-9fde-9b76083962b5 61 fields · synced Jul 10, 2026
- EUDAMED ebf87de2-b958-4872-a8df-36d8b9af3369 61 fields · synced Jul 11, 2026
- EUDAMED fd276a06-c6c9-41e6-bb03-7340a8412baf 61 fields · synced Jul 12, 2026
- EUDAMED 9b8bf6cc-bd19-42f5-a54f-23a0ef5b741f 61 fields · synced Jul 13, 2026
- EUDAMED 1908d476-64bf-4e08-b3e3-6baee90ebe87 61 fields · synced Jul 14, 2026
- EUDAMED 19698e0f-608d-47ec-95a9-a71ceb527efe 61 fields · synced Jul 14, 2026
- EUDAMED 480c6402-0ee9-4f9c-a83e-83634e56ab5a 61 fields · synced Jul 14, 2026
- EUDAMED 81ddbb39-dedc-4880-8172-3853e2e0d115 61 fields · synced Jul 15, 2026
- EUDAMED 11d4bc35-2ec0-45d7-bd2d-4a74d63ad0a9 61 fields · synced Jul 15, 2026
- EUDAMED cfb2a491-1489-4dcd-9ab7-67e0e65203ec 61 fields · synced Jul 16, 2026
- EUDAMED fdc7b887-6a04-4fa8-8a50-ad16b0859720 61 fields · synced Jul 17, 2026
- EUDAMED ce650130-2abc-4ace-9e3c-89ffec219b50 61 fields · synced Jul 21, 2026
- EUDAMED 0ac5e85d-e0f3-4684-afb4-46bf9d806bd7 61 fields · synced Jul 23, 2026
- EUDAMED 3f5c47f5-5ecc-4fb9-889b-3dda9430645a 61 fields · synced Jul 29, 2026
- EUDAMED da9020a5-6f6a-40d3-b069-aec6265cbfad 61 fields · synced Jul 30, 2026
- EUDAMED 594ac44f-649d-4550-8338-4821b7d766b1 61 fields · synced Aug 3, 2026