INVISIO®DIGITAL FLEXIBLE CYSTONEPHROSCOPE 5.5 mm, 37 cm, 6.6 Fr chann
GUDID 00821925027480
Gyrus Acmi, Inc.
Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Flexible video cystoscope, reusable Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope| 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
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.
| 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 |
| 00821925041455 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.