← Back to catalogue
Neoss Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 51184
by Neoss, Ltd.
Identity
- Trade Name
- iGO Screwdriver, Machine 32 mm EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Handpiece connection instrument EUDAMEDiGO Screwdriver, Machine 32mm FDA UDI
- Model / Reference
- 51184 EUDAMEDFDA UDI
- Description
- iGO Screwdriver, Machine 32mm FDA UDI
Identifiers
- Catalog Number
- 51184 FDA UDI
- Primary DI / UDI-DI
- 05060440333583 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0035N4 EUDAMED
- Direct Marketing DI
- 05060440333583 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES 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
- Germany 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Neoss Implant System by Neoss, 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
- 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
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
- Neoss, Ltd.
Sources (2)
- FDA UDI d7572fd6-e25b-4295-a3fe-69591117f513 35 fields · synced Aug 2, 2026
- EUDAMED 95bc99aa-7cd4-4c1d-aec5-78040b239cd9 61 fields · synced Aug 2, 2026