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Saw Protector
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OSP130Ref HSP100Ref HSP070
Identity
- Trade Name
- Saw Protector EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OSP130 EUDAMEDFDA UDIHSP070 EUDAMEDFDA UDIHSP100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917121912 EUDAMEDFDA UDI08809917121868 EUDAMEDFDA UDI08809917121875 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4130 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 drill guide, single-use
Saw Protector by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical drill guide, single-use.
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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 (6)
- FDA UDI f2bb82c4-3577-4b74-9853-0a5219613eeb 32 fields · synced Aug 4, 2026
- FDA UDI 665f262e-043f-45d8-ac38-0410f2f4f2f5 32 fields · synced May 30, 2026
- FDA UDI 43d25a28-e97e-4059-8717-70f4135c42d6 32 fields · synced May 30, 2026
- EUDAMED b61b885f-85ae-4b48-ad9d-08bb66b690ab 61 fields · synced Jul 9, 2026
- EUDAMED d927561d-c126-49e0-a78e-ba179e9423fc 61 fields · synced Jul 13, 2026
- EUDAMED 049eae3d-6dc1-4d75-a79f-ea03c69f9416 61 fields · synced Aug 4, 2026