AVR NAVIGATOR™ 081446
GUDID 10850012846298
AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE
LSI Solutions, Inc.
Aortic root retraction system| Primary Device ID | 10850012846298 |
| NIH Device Record Key | c7931003-eb2f-4157-921d-f74d81e198e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVR NAVIGATOR™ |
| Version Model Number | 081446 |
| Catalog Number | 081446 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com |
Device Dimensions
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
| Lumen/Inner Diameter | 19 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850012846291 [Primary] |
| GS1 | 10850012846298 [Package] Contains: 00850012846291 Package: Case [6 Units] In Commercial Distribution |
FDA Product Code
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-12 |
| Device Publish Date | 2024-02-02 |
On-Brand Devices [AVR NAVIGATOR™]
| 10850012846311 | AVR NAVIGATOR™ LARGE RETRACTOR WITH DELIVERY DEVICE |
| 10850012846304 | AVR NAVIGATOR™ MEDIUM RETRACTOR WITH DELIVERY DEVICE |
| 10850012846298 | AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE |
Trademark Results [AVR NAVIGATOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVR NAVIGATOR 97560896 not registered Live/Pending |
LSI Solutions, Inc. 2022-08-23 |
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