INVISIO®DIGITAL FLEXIBLE CYSTONEPHROSCOPE 5.5 mm, 37 cm, 6.6 Fr chann
GUDID 00821925027480
Gyrus Acmi, Inc.
Flexible video cystoscope, reusable| Primary Device ID | 00821925027480 |
| NIH Device Record Key | 8af1ab21-8703-46be-94ef-879bec694f7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INVISIO®DIGITAL FLEXIBLE CYSTONEPHROSCOPE 5.5 mm, 37 cm, 6.6 Fr chann |
| Version Model Number | REXICN-2 |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925027480 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042225
FDA Product Code
| FAJ | Cystoscope and accessories, flexible/rigid |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
[00821925027480]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-11 |
Devices Manufactured by Gyrus Acmi, Inc.
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| 00821925043978 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043992 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron |
| 00821925044074 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron |
| 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 [INVISIO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVISIO 98269045 not registered Live/Pending |
LMPG Inc. 2023-11-14 |
 INVISIO 87355657 not registered Dead/Abandoned |
CUNNINGHAM LINDSEY U.S. LLC 2017-03-02 |
 INVISIO 85935997 4507982 Live/Registered |
PolyOne Corporation 2013-05-17 |
 INVISIO 79200188 5348259 Live/Registered |
Cunningham Lindsey IP Holdings and Services Limited 2016-06-06 |
 INVISIO 78841964 3205713 Live/Registered |
INVISIO COMMUNICATIONS A/S 2006-03-21 |
 INVISIO 78451703 3094155 Live/Registered |
GYRUS ACMI, INC. 2004-07-16 |
 INVISIO 76211936 not registered Dead/Abandoned |
NEXTLINK.TO A/S 2001-02-16 |
 INVISIO 75770038 2545735 Dead/Cancelled |
Invisio, Inc. 1999-08-30 |
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