Identity
- Trade Name
- NAVIGATOR® EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Non-Sterile Manual Dental Instruments EUDAMEDNAVIGATOR® MASTER TUBE (PACK OF 25) 4.1MM(D) X 4MM(H) FDA UDI
- Model / Reference
- SGMT44 EUDAMEDFDA UDI
- Description
- NAVIGATOR® MASTER TUBE (PACK OF 25) 4.1MM(D) X 4MM(H) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868016151 EUDAMEDFDA UDI
- Basic UDI-DI
- 844868A2GU EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Category: Surgical drill guide, reusable
Navigator® by Biomet 3i, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, 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
- Biomet 3i, Llc
Sources (2)
- FDA UDI a834d2a2-55d6-4c0f-a81d-0bb0579b971a 35 fields · synced Jul 25, 2026
- EUDAMED 33f2fabf-bf97-488c-9bea-726798778cd8 61 fields · synced Jul 25, 2026