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Neoss Implant System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 41210
by Neoss, Ltd.
Identity
- Trade Name
- Countersink, Edge Ø3.5 EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Surgical countersink, reusable FDA UDI
- Device Name
- Reusable Drill EUDAMEDCountersink Edge Ø3.5 FDA UDI
- Model / Reference
- 41210 EUDAMEDFDA UDI
- Description
- Countersink Edge Ø3.5 FDA UDI
Identifiers
- Catalog Number
- 41210 FDA UDI
- Primary DI / UDI-DI
- 05060440334368 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0016MY EUDAMED
- Direct Marketing DI
- 05060440334368 EUDAMED
- FDA Product Code
- DZI FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical countersink, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical countersink, reusable
Neoss Implant System by Neoss, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical countersink, reusable.
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- Cortical Counter Sink — I.T.S. GmbH · Class I
- 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neoss, Ltd.
Sources (2)
- FDA UDI b52d1dd1-facd-4101-bd53-49c983d4529e 35 fields · synced Jul 10, 2026
- EUDAMED c71ccdc0-7d53-4e3c-ae21-45750af9a064 61 fields · synced Jul 10, 2026