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123 Drill Stop
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref HODST13Ref HODST15Ref HODST06
Identity
- Trade Name
- 123 Drill Stop EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- HODST06 EUDAMEDFDA UDIHODST15 EUDAMEDFDA UDIHODST13 EUDAMEDFDA UDIHODST08 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209369326 EUDAMEDFDA UDI08800209369388 EUDAMEDFDA UDI08800209369371 EUDAMEDFDA UDI08800209369340 FDA 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
123 Drill Stop 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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- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- 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 (7)
- FDA UDI d704b428-c0b4-4eb2-8005-79506d551307 32 fields · synced Jul 22, 2026
- FDA UDI c04c122c-66e6-454e-92dc-ce69f4103ea0 32 fields · synced May 24, 2026
- FDA UDI e91ec492-1484-4a57-9ae7-efd09c20633a 32 fields · synced May 30, 2026
- FDA UDI 9cb73eb7-caed-4ccc-a35d-c2f17b02ba4a 32 fields · synced May 30, 2026
- EUDAMED 1cc260cc-e4b1-4c11-899e-9656fa094d71 61 fields · synced Jul 16, 2026
- EUDAMED ef0f7c4a-2597-43a5-8793-3a40abc4d265 61 fields · synced Jul 17, 2026
- EUDAMED 8ca74d54-feb7-4516-8357-af7145433447 61 fields · synced Jul 22, 2026