Identity
- Trade Name
- eNV™ FDA UDI
- Generic Name
- ENT stereotactic surgery system FDA UDI
- Device Name
- INSTRUMENT 9731249XOM ENV HEAD TRACKER FDA UDI
- Model / Reference
- 9731249XOM FDA UDI
- Description
- INSTRUMENT 9731249XOM ENV HEAD TRACKER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885074517490 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- ENT stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ENT stereotactic surgery system
eNV™ by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT stereotactic surgery system.
- FlexPointer 1.5 single use — Fiagon GmbH · Class II
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
- Ascension MCP Joint Replacement — Smith & Nephew, Inc. · Class I
- NuGrip CMC — Smith & Nephew, Inc. · Class I
- Truliant — Exactech, Inc. · Class I
- NaviENT — ClaroNav Kolahi Inc · Class II
- AESCULAP — AESCULAP, INC. · Class I
- FlexTube 3 single use — Fiagon GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA UDI 6a43c7da-800b-4e02-bb4f-8468880c8f0a 34 fields · synced Jun 8, 2026