| Primary Device ID | 00851354004264 |
| NIH Device Record Key | aba2f708-cf54-414d-8081-9393bb6e1daa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterile Drape |
| Version Model Number | SD100 |
| Catalog Number | SD100 |
| Company DUNS | 003152968 |
| Company Name | AVINGER, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com | |
| Phone | 650-241-7030 |
| tlawson@avinger.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851354004264 [Primary] |
| KKK | Sudan Iv |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
[00851354004264]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-29 |
| Device Publish Date | 2019-03-21 |
| 00851354004509 - Lightbox L3 | 2024-02-06 The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the de |
| 00851354004578 - Pantheris LV | 2024-02-06 The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F |
| 00851354004554 - Tigereye ST | 2023-08-01 The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions |
| 00851354004493 - Tigereye | 2023-03-22 The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (inclu |
| 00851354004417 - Pantheris SV | 2019-08-12 The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature |
| 00851354004004 - Wildcat | 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to |
| 00851354004028 - Wildcat | 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to |
| 00851354004042 - Kittykat II | 2019-03-29 "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It |