Identity
- Trade Name
- AVR NAVIGATOR™ FDA UDI
- Generic Name
- Aortic root retraction system FDA UDI
- Device Name
- AVR NAVIGATOR™ LARGE RETRACTOR WITH DELIVERY DEVICE FDA UDI
- Model / Reference
- 081458 FDA UDI
- Description
- AVR NAVIGATOR™ LARGE RETRACTOR WITH DELIVERY DEVICE FDA UDI
Identifiers
- Catalog Number
- 081458 FDA UDI
- Primary DI / UDI-DI
- 00850012846314 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Aortic root retraction system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 23 Millimeter FDA UDI
Category: Aortic root retraction system
Avr Navigator™ by LSI Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic root retraction system.
- MI CUFF - Aortic Root Exposure Device — BIOREP TECHNOLOGIES, INC. · Class I
- AVR NAVIGATOR™ — LSI Solutions, Inc. · Class I
- AORTIC ROOT RETRACTOR — LSI Solutions, Inc. · Class I
- AVR NAVIGATOR™ — LSI Solutions, Inc. · Class I
- AORTIC ROOT RETRACTOR — LSI Solutions, Inc. · Class I
- AORTIC ROOT RETRACTOR — LSI Solutions, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- LSI Solutions, Inc.
Sources (1)
- FDA UDI 5282356f-0d86-4eb3-8c71-a5757299683b 36 fields · synced May 30, 2026