Primary Device ID | 00821925043343 |
NIH Device Record Key | 044efe68-8ab9-486a-8627-320f4ebc486f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CleverLock |
Version Model Number | MAJ-2455 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00821925043336 [Package] Package: [10 Units] In Commercial Distribution |
GS1 | 00821925043343 [Primary] |
ODC | Endoscope Channel Accessory |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-01 |
Device Publish Date | 2024-07-24 |
00821925043916 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron |
00821925043930 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEVERLOCK 88505948 not registered Live/Pending |
Olympus Corporation 2019-07-09 |