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OneMS TS Implant Driver (Stopper Type)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref HOCDS03WRef HOCDS08WRef OLSNST0.5Ref HUSWFDLRef HOCDS09Ref OSNST7Ref OABC2ST604SRef OGFDSM35Ref HOCDS06WRef OLSNST1.5Ref HOCDS02WRef HOCDS05Ref OGFDM35Ref OSNST2Ref HOCDS09WRef OLSNST2.0Ref OSNST11Ref HOCDS01Ref HOCDS04WRef OSNST9Ref OSNST8Ref OABC2ST604LRef HOCDS03Ref OSNST10
Identity
- Trade Name
- OneMS TS Implant Driver (Stopper Type) EUDAMEDFDA UDIStopper EUDAMEDFDA UDIOneMS TS Implant Driver EUDAMEDFDA UDIImplant Driver EUDAMEDFixture Driver FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDISurgical drill guide, reusable FDA UDIFixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OGFDSM35 EUDAMEDFDA UDIOSNST7 EUDAMEDFDA UDIOSNST11 EUDAMEDFDA UDIHOCDS05 EUDAMEDFDA UDIOSNST9 EUDAMEDFDA UDIOGFDM35 EUDAMEDFDA UDIHOCDS09W EUDAMEDFDA UDIOLSNST0.5 EUDAMEDFDA UDIHOCDS04W EUDAMEDFDA UDIHOCDS01 EUDAMEDFDA UDIHOCDS09 EUDAMEDFDA UDIOLSNST1.5 EUDAMEDFDA UDIOABC2ST604S EUDAMEDFDA UDIOSNST8 EUDAMEDFDA UDIHUSWFDL EUDAMEDFDA UDIOSNST10 EUDAMEDFDA UDIHOCDS03 EUDAMEDFDA UDIOLSNST2.0 EUDAMEDFDA UDIHOCDS06W EUDAMEDFDA UDIHOCDS03W EUDAMEDFDA UDIOABC2ST604L EUDAMEDFDA UDIHOCDS02W EUDAMEDFDA UDIHOCDS08W EUDAMEDFDA UDIOSNST2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917109187 EUDAMEDFDA UDI08809917070906 EUDAMEDFDA UDI08809917070838 EUDAMEDFDA UDI08800209369180 EUDAMEDFDA UDI08809917070920 EUDAMEDFDA UDI08809917109101 EUDAMEDFDA UDI08800209369272 EUDAMEDFDA UDI08809917070654 EUDAMEDFDA UDI08800209369173 EUDAMEDFDA UDI08800209369104 EUDAMEDFDA UDI08800209369265 EUDAMEDFDA UDI08809917070678 EUDAMEDFDA UDI08809917070470 EUDAMEDFDA UDI08809917070913 EUDAMEDFDA UDI08800209374139 EUDAMEDFDA UDI08809917070821 EUDAMEDFDA UDI08800209369142 EUDAMEDFDA UDI08809917070685 EUDAMEDFDA UDI08800209369210 EUDAMEDFDA UDI08800209369159 EUDAMEDFDA UDI08809917070463 EUDAMEDFDA UDI08800209369135 EUDAMEDFDA UDI08800209369258 EUDAMEDFDA UDI08809917070852 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDIDZA FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDISurgical drill guide, reusable FDA UDIFixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI872.4130 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
OneMS TS Implant Driver (Stopper Type) 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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- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
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- PERLA ® TL — Spineart · Class II
- 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 (48)
- FDA UDI 3ebd7120-167f-47e6-80c3-fd33f663f177 32 fields · synced Sep 17, 2026
- FDA UDI 4b71eb32-2887-4b1c-b201-2e9a4667614c 32 fields · synced May 29, 2026
- FDA UDI 767d09c3-8761-42aa-af5e-b7339894ec21 32 fields · synced May 29, 2026
- FDA UDI e122bcc6-e828-4131-bca8-9bee22fa5553 32 fields · synced May 29, 2026
- FDA UDI 08b493b4-acd7-4b81-88ef-5521af6d2b36 32 fields · synced May 30, 2026
- FDA UDI 87deb73f-2843-4dcd-8cb9-ecd286079b4a 32 fields · synced May 30, 2026
- FDA UDI eeb51932-7de4-4293-9f81-ad59d2a477ff 32 fields · synced May 30, 2026
- FDA UDI c799a791-dba6-4efd-8625-301e9b9a63d6 32 fields · synced May 30, 2026
- FDA UDI 61e56981-e691-4452-bdec-60d43713d26a 32 fields · synced May 30, 2026
- FDA UDI abcc5457-631c-4110-86e8-2fcbe5584b15 32 fields · synced May 30, 2026
- FDA UDI fe088068-dc55-4671-8aa5-0d50a0eff15e 32 fields · synced May 30, 2026
- FDA UDI 30e176e4-0a2e-4d4f-8c4c-69fc095694e9 32 fields · synced May 30, 2026
- FDA UDI 636d7811-0cbc-4818-853b-b49217f22017 32 fields · synced May 30, 2026
- FDA UDI 3c4aaea8-c070-4431-a1f6-68435f1cbe11 32 fields · synced May 30, 2026
- FDA UDI 9d6bf18d-4947-4234-9832-e700033af9d6 32 fields · synced May 30, 2026
- FDA UDI 16ee41e9-8cfc-419b-9519-168be7fe3c4a 32 fields · synced May 30, 2026
- FDA UDI 274f2426-b9c9-47cd-8253-fead451e732f 32 fields · synced May 30, 2026
- FDA UDI de4ecf06-6fa5-4e95-a925-a7314edc9842 32 fields · synced May 30, 2026
- FDA UDI 07060c22-935b-40b7-89c6-a7d7425c3981 32 fields · synced May 30, 2026
- FDA UDI b61c941b-d867-4868-ab8e-cbd2d6ba66d4 32 fields · synced May 30, 2026
- FDA UDI b692caac-b782-4b0b-a657-090bc5a71ae4 32 fields · synced May 30, 2026
- FDA UDI 5f694185-0673-4665-ae8b-7ac798fb1472 32 fields · synced May 30, 2026
- FDA UDI 10a92cf5-948c-48e0-9485-dcd41d08b08a 32 fields · synced May 30, 2026
- FDA UDI bfac0f7e-e998-41c6-ab83-ee12eb4f1471 32 fields · synced May 30, 2026
- EUDAMED b2f7d636-08ed-42f7-91be-ecf124264152 61 fields · synced Jul 10, 2026
- EUDAMED 67258b4b-11f0-4f96-9654-74bf9721cf0f 61 fields · synced Jul 11, 2026
- EUDAMED ee2846de-440f-45db-b825-4d035d521d38 61 fields · synced Jul 12, 2026
- EUDAMED 171aacd8-5437-4b96-b6f9-3a18b1c3a2b1 61 fields · synced Jul 12, 2026
- EUDAMED ef5e5502-d882-4722-82fa-5d1b2b794837 61 fields · synced Jul 13, 2026
- EUDAMED 22a1e331-08e4-4b9d-81f6-7e5865f3ce27 61 fields · synced Jul 15, 2026
- EUDAMED 68d3c880-89da-4789-9059-dcf330b26fae 61 fields · synced Jul 15, 2026
- EUDAMED 542e8bd6-9922-4b65-9bba-60a00264e403 61 fields · synced Jul 17, 2026
- EUDAMED 8d9ee62b-b110-4e4a-98a7-9da9b3326f9a 61 fields · synced Jul 18, 2026
- EUDAMED 43f9b3eb-6a9e-438d-9467-0f28bc4ecf3c 61 fields · synced Jul 18, 2026
- EUDAMED 63f25393-27f8-4c27-a14a-ed52f4ff6ca9 61 fields · synced Jul 21, 2026
- EUDAMED 4cc3f3f9-9786-4759-b400-49d359b2d657 61 fields · synced Jul 22, 2026
- EUDAMED 892cb11b-19be-4a9e-af00-812533bae371 61 fields · synced Jul 24, 2026
- EUDAMED 5af84645-3e35-42c3-b1ce-a7d4bf895a92 61 fields · synced Jul 24, 2026
- EUDAMED 2d065149-7313-4ea9-9d1b-2a44473337a3 61 fields · synced Jul 25, 2026
- EUDAMED 2f986f8c-488a-4b91-ae91-73cff7e91f5f 61 fields · synced Jul 28, 2026
- EUDAMED 198b572e-85fc-4d1c-99aa-5904a8b1f174 61 fields · synced Jul 28, 2026
- EUDAMED 57c02aaf-277b-4459-9692-87e47b1409cd 61 fields · synced Jul 29, 2026
- EUDAMED e401832e-830c-44fb-8f99-df939bf0f0b3 61 fields · synced Jul 30, 2026
- EUDAMED a846dc4d-e685-4e90-8ad8-1e414b14e89c 61 fields · synced Aug 3, 2026
- EUDAMED fec2269e-1405-45ef-9ce3-037c1e42c202 61 fields · synced Aug 3, 2026
- EUDAMED d818733b-5cb2-4252-9916-659848122e5b 61 fields · synced Aug 4, 2026
- EUDAMED bd13dd32-3137-4f94-a752-78b96c3e1aa5 61 fields · synced Aug 4, 2026
- EUDAMED f898e0d5-1182-4b10-bd8f-2e963a5056d4 61 fields · synced Sep 17, 2026