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KS Remover Screw
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref KSFRSR40Ref HKSFRSR40FRef KSFRSW50Ref KSFRSR40FRef HKSFRSW50FRef HKSFRSM35FRef KSFRSM35F
Identity
- Trade Name
- KS Remover Screw EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- HKSFRSR40F EUDAMEDFDA UDIKSFRSR40F EUDAMEDFDA UDIHKSFRSM35F EUDAMEDFDA UDIKSFRSR40 EUDAMEDFDA UDIKSFRSM35F EUDAMEDFDA UDIKSFRSW50 EUDAMEDFDA UDIHKSFRSW50F EUDAMEDFDA UDIHKSFRSM35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209368206 EUDAMEDFDA UDI08809892358068 EUDAMEDFDA UDI08800209368183 EUDAMEDFDA UDI08809892358075 EUDAMEDFDA UDI08809892358044 EUDAMEDFDA UDI08809892358099 EUDAMEDFDA UDI08800209368220 EUDAMEDFDA UDI08800209368176 FDA 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
Category: Surgical screwdriver, single-use
KS Remover Screw by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (15)
- FDA UDI e649f32c-65a5-4974-95d8-11e37bcb5533 32 fields · synced Jul 29, 2026
- FDA UDI 028c8fd0-a6f8-4ff1-8d6d-46c57443e503 32 fields · synced May 25, 2026
- FDA UDI 70fbae76-a8e5-4b0f-b3ff-96c90b4bde11 32 fields · synced May 26, 2026
- FDA UDI f06a14a1-61ce-4e7a-87e8-dc4f15a96fc2 32 fields · synced May 29, 2026
- FDA UDI cf8190eb-2cc0-4090-80ef-5c71b061dd49 32 fields · synced May 30, 2026
- FDA UDI 30e29024-89d5-4273-b481-e5012c1d445f 32 fields · synced May 30, 2026
- FDA UDI aa8f623a-896b-4fe7-bca4-b427c67eb000 32 fields · synced May 30, 2026
- FDA UDI 20cf7e0a-db89-4f31-9392-fdd18fb66406 32 fields · synced May 30, 2026
- EUDAMED 60784733-ac4c-41b1-b617-900564ca7d5a 61 fields · synced Jun 20, 2026
- EUDAMED 7f84b432-a959-46ec-a747-ae6583f8bd4f 61 fields · synced Jul 9, 2026
- EUDAMED 811e7d68-9026-4942-9a39-dc4b964ab25e 61 fields · synced Jul 10, 2026
- EUDAMED c53a1605-1456-4d59-86f2-eafbc40b810b 61 fields · synced Jul 17, 2026
- EUDAMED d63ddaf7-4a5e-4dc1-9cc8-c67061e81769 61 fields · synced Jul 20, 2026
- EUDAMED 747fd23f-f6bc-497f-93d7-67d1d070a4ea 61 fields · synced Jul 26, 2026
- EUDAMED c3dafac6-1364-4177-827d-011bd920b7d9 61 fields · synced Jul 29, 2026