Primary Device ID | 00860003054901 |
NIH Device Record Key | 0e0fea1d-e853-4e90-acc9-0224abc217d0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CLR Irrigator |
Version Model Number | S012-01-019 |
Company DUNS | 080279373 |
Company Name | CLR Medical |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860003054901 [Primary] |
GS1 | 00860003054987 [Package] Package: [5 Units] In Commercial Distribution |
GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-06 |
Device Publish Date | 2024-05-29 |
00850052377021 - CLR Port Injector | 2024-06-06 |
00860003054901 - CLR Irrigator | 2024-06-06 |
00860003054901 - CLR Irrigator | 2024-06-06 |
00860003054956 - CLR Port | 2024-06-06 |
00850052377014 - CLR Port Cap | 2024-06-06 |
00860003054949 - CLR Medical | 2021-11-15 |