ViziShot FLEX
GUDID 00896506002132
Single Use Aspiration Needle
Gyrus Acmi, Inc.
Flexible endoscopic biopsy handpiece/needle| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00896506002132 [Primary] |
FDA Product Code
| KTI | Bronchoscope Accessory |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-04 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by Gyrus Acmi, Inc.
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| 00821925002074 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002098 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002111 - USA Elite System | 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold |
Trademark Results [ViziShot FLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIZISHOT FLEX 86829223 5107846 Live/Registered |
Olympus Corporation 2015-11-23 |
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