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Abutment Removal Tip
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OARTRSRef OARTMELRef HARTMELRef HARTRS
Identity
- Trade Name
- Abutment Removal Tip EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OARTMEL EUDAMEDFDA UDIHARTMEL EUDAMEDFDA UDIOARTRS EUDAMEDFDA UDIHARTRS EUDAMEDFDA UDIHOARTRL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809892360603 EUDAMEDFDA UDI08800209366004 EUDAMEDFDA UDI08809892360665 EUDAMEDFDA UDI08800209366035 EUDAMEDFDA UDI08800209368800 FDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, 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 screwdriver, reusable
Abutment Removal Tip 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.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
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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 (9)
- FDA UDI 2e0413f6-ea8d-4d03-8109-87b2f05f4c67 32 fields · synced Sep 17, 2026
- FDA UDI bf32ba25-01b1-4a39-ac56-dab4f9982131 32 fields · synced May 29, 2026
- FDA UDI f71f1059-53f5-4af0-b29f-6b39083bc3fc 32 fields · synced May 30, 2026
- FDA UDI 5db75a48-c131-431b-982b-16f94df9003f 32 fields · synced May 30, 2026
- FDA UDI 97057619-d383-432d-89c0-8b0a47951019 32 fields · synced May 30, 2026
- EUDAMED d39e4dc7-601e-4af8-a900-ac67168dd374 61 fields · synced Jul 11, 2026
- EUDAMED d5f093ec-26cf-4421-987f-2c68daf153f2 61 fields · synced Jul 15, 2026
- EUDAMED b349d7b6-d95d-4970-812b-31cc2ff9eb22 61 fields · synced Aug 3, 2026
- EUDAMED 8c1f3053-fc95-4800-a18f-5415692b5c79 61 fields · synced Sep 17, 2026