Primary Device ID | 03700512922018 |
NIH Device Record Key | 76ad3426-ac24-4bbe-8458-78d637fd92c5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Urology Gravity Laser Cooling Line |
Version Model Number | GB1BPH |
Catalog Number | ONGR2001ST12 |
Company DUNS | 401020409 |
Company Name | Promepla |
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 | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03700512902010 [Primary] |
GS1 | 03700512912019 [Package] Contains: 03700512902010 Package: Box Label 1 [10 Units] In Commercial Distribution |
GS1 | 03700512922018 [Package] Contains: 03700512902010 Package: Box Label 2 [4 Units] In Commercial Distribution |
GBX | Catheter, Irrigation |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-11 |
Device Publish Date | 2019-10-18 |