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Neoss Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 41202
by Neoss, Ltd.
Identity
- Trade Name
- Countersink Ø6.0 EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Surgical countersink, reusable FDA UDI
- Device Name
- Reusable Drill EUDAMEDCountersink Ø6.0 FDA UDI
- Model / Reference
- 41202 EUDAMEDFDA UDI
- Description
- Countersink Ø6.0 FDA UDI
Identifiers
- Catalog Number
- 41202 FDA UDI
- Primary DI / UDI-DI
- 05060440332241 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0016MY EUDAMED
- Direct Marketing DI
- 05060440332241 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical countersink, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical countersink, reusable
Neoss Implant System by Neoss, Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical countersink, reusable.
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- EVOS — Smith & Nephew, Inc. · Class I
- PERLA ® — Spineart · Class II
- DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC. · 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 |
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Manufacturer
- Manufacturer
- Neoss, Ltd.
Sources (2)
- FDA UDI 05574c38-11b1-4110-84f9-ccea1867075d 35 fields · synced Jul 9, 2026
- EUDAMED 628ad346-1ad8-4369-8481-02b925977218 61 fields · synced Jun 20, 2026