| 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 |