Identity
- Trade Name
- US Pick-up Guide Pin EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDIDental prosthesis/implant abutment screw analog, reusable FDA UDI
- Device Name
- Impression Tool System EUDAMED
- Model / Reference
- GPW100 EUDAMEDFDA UDIGPW150 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000935614 EUDAMEDFDA UDI08809892341794 EUDAMEDFDA UDI08809892341787 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBUSANHY EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDIDental prosthesis/implant abutment screw analog, 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
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDIFDA UDI
Reusable
No
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
US Pick-up Guide Pin by Osstem Implant Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000406CLASSIBUSANHY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED 9dd8353a-5750-43bb-b469-8f26c2814249 61 fields · synced Sep 30, 2026
- FDA UDI 5067deda-c523-4bab-bfb1-7e7fd38c9a0b 32 fields · synced May 29, 2026
- FDA UDI 7d659791-bf39-4d37-9c89-4a064daf430c 32 fields · synced May 30, 2026
- FDA UDI c179abe6-bdeb-4127-840d-29d5ccfcdcb2 32 fields · synced May 30, 2026
- EUDAMED 166bc6a9-823e-46ce-9ece-119b9ce06680 61 fields · synced Sep 17, 2026
- EUDAMED 9097ac1c-ea44-43b9-925c-efa0630dfe8a 61 fields · synced Sep 17, 2026