Retrowash

GUDID 25060485740012

Retrowash On-Table Lavage/Bowel Washout Kit, 46mm version, for intra-operative washout of the colon in emergency obstructions. The 46mm version is for use where the bowel is distended. After washout, the device facilitates on-table colonoscopy if desired. Sterile. Comprised of 1 x 46mm Handpiece Assembly with 1.6m waste tubing; 1.5m Giving Set; 1.0m Extension Set; 4 x Ties; 2 x 10l Cubitainer waste receptacles.

INTERMARK MEDICAL INNOVATIONS LIMITED

Colonic lavage kit, surgical

• Primary Device ID: 25060485740012
• NIH Device Record Key: 27e854eb-1b2b-42e2-a4d5-bf54ac92bbcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retrowash
• Version Model Number: RW46
• 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

Customer Support Contacts

• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com
• Phone: 801 571 2295
• Email: customerservice@stonemountainsurgical.com

Device Dimensions

• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485740018 [Primary]
GS1	25060485740012 [Package]; Contains: 05060485740018; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• KOA: Surgical Instruments, G-U, Manual (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [Retrowash]

• 25060485740012: Retrowash On-Table Lavage/Bowel Washout Kit, 46mm version, for intra-operative washout of the co
• 25060485740005: Retrowash On-Table Lavage/Bowel Washout Kit, 35mm version, for intra-operative washout of the co