Primary Device ID | 85060485740021 |
NIH Device Record Key | efce70e0-dd14-4264-81b1-8b60c72253a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Proctowash |
Version Model Number | PR01 |
Company DUNS | 519829832 |
Company Name | INTERMARK MEDICAL INNOVATIONS LIMITED |
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 | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com | |
Phone | 801 571 2295 |
customerservice@stonemountainsurgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05060485740025 [Primary] |
GS1 | 85060485740021 [Package] Contains: 05060485740025 Package: [10 Units] In Commercial Distribution |
FGM | Probe And Director, Gastro-Urology |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-19 |
Device Publish Date | 2023-06-09 |
25060485740005 - Retrowash | 2023-06-19 Retrowash On-Table Lavage/Bowel Washout Kit, 35mm version, for intra-operative washout of the colon in emergency obstructions. T |
25060485740012 - Retrowash | 2023-06-19 Retrowash On-Table Lavage/Bowel Washout Kit, 46mm version, for intra-operative washout of the colon in emergency obstructions. T |
85060485740021 - Proctowash | 2023-06-19Proctowash Rectal Stump Washout Kit for elimination of exfoliated tumour cells from the rectal stump in colorectal cancer procedures. Rectal washout for intra-operative prepping of the rectum whenever required. Non-sterile. Comprised of 1 x Handset/probe with flexible atraumatic tip, 1 x 2.5m Giving Set, 1 x 0.8m Waste Tubing, 1 x 3l Cubitainer waste receptacle. |
85060485740021 - Proctowash | 2023-06-19 Proctowash Rectal Stump Washout Kit for elimination of exfoliated tumour cells from the rectal stump in colorectal cancer proced |