Identity
- Trade Name
- NeoGuide IS Fixture Driver(Contra Angle Type) EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Contra Angle, Narrow FDA UDI
- Model / Reference
- NGISFDCANA EUDAMEDFDA UDI
- Description
- Contra Angle, Narrow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809815658442 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809815658442 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical screwdriver, reusable
The Neobiotech Implant System is a non-powered tool designed for surgeons to introduce/remove screws (e.g., craniofacial bone screw, dental screw) into/from patients during surgical procedures. This reusable device can be used with various types of chucks or power drivers.
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- 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
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neobiotech. co., ltd
Sources (2)
- FDA UDI 0b29d039-f2b2-44d7-a1e1-d29360cc0926 33 fields · synced Jul 6, 2026
- EUDAMED d9b1567d-15c7-496b-b8d0-a4b863623511 61 fields · synced Jun 19, 2026