Identity
- Trade Name
- KS Guide EUDAMEDFDA UDIEK guide EUDAMED
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- HKGRL EUDAMEDFDA UDIOKGRL EUDAMEDFDA UDIOKGRS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209368053 EUDAMEDFDA UDI08809892362072 EUDAMEDFDA UDI08809892362089 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, 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
Category: Surgical drill guide, reusable
KS Guide 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 drill guide, reusable.
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- Hintermann Series — Dt Medtech, 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 |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (6)
- FDA UDI 80d41a76-60ac-4f50-a66f-189ac3512c9c 32 fields · synced Jul 21, 2026
- FDA UDI 5e11e995-5f61-4258-b80d-c822ededc73b 32 fields · synced May 30, 2026
- FDA UDI 69ab3485-1ef3-4f64-8692-69e93dcdeab1 32 fields · synced May 30, 2026
- EUDAMED 1a9822c0-7581-4e34-8493-7eecb987410a 61 fields · synced Jun 19, 2026
- EUDAMED fe7d22ff-f54b-4b62-a071-f17c0429d398 61 fields · synced Jul 9, 2026
- EUDAMED 76dadc8a-dac6-44be-b68e-a26209b7968a 61 fields · synced Jul 21, 2026