Primary Device ID | 00896506002132 |
NIH Device Record Key | 99cdf1cd-16b1-43b5-8e55-11d7bdf3496b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ViziShot FLEX |
Version Model Number | NA-U402SX-4019 |
Company DUNS | 117521967 |
Company Name | Gyrus Acmi, 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 | false |
Expiration Date | true |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00896506002132 [Primary] |
KTI | Bronchoscope Accessory |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-03-04 |
Device Publish Date | 2016-09-24 |
00821925000292 - SURGIFLEX | 2024-07-15 SURGIFLEX Suction-Irrigating Probe Reusable Electrode w/Luer Lok Connector Spatula, 5 mm X 32 cm |
00821925015708 - Gyrus ACMI | 2024-06-18 SCHUKNECHT CRESCENT FLUOROPLASTIC |
00821925041394 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR |
00821925041400 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR |
00821925041417 - InstaClear | 2024-04-30 SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR |
00821925041424 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR |
00821925041431 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR |
00821925041448 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VIZISHOT FLEX 86829223 5107846 Live/Registered |
Olympus Corporation 2015-11-23 |