Retrowash

GUDID 25060485740005

Retrowash On-Table Lavage/Bowel Washout Kit, 35mm version, for intra-operative washout of the colon in emergency obstructions. The 35mm version is for use where there is little or no bowel distension. After washout, the device facilitates on-table colonoscopy if desired. Sterile. Comprised of 1 x 35mm 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

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Primary Device ID25060485740005
NIH Device Record Key63b7944c-6450-4a88-a1d3-654eb32d313b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetrowash
Version Model NumberRW35
Company DUNS519829832
Company NameINTERMARK MEDICAL INNOVATIONS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com
Phone801 571 2295
Emailcustomerservice@stonemountainsurgical.com

Device Dimensions

Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105060485740001 [Primary]
GS125060485740005 [Package]
Contains: 05060485740001
Package: [2 Units]
In Commercial Distribution

FDA Product Code

KOASurgical Instruments, G-U, Manual (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

On-Brand Devices [Retrowash]

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