FDA.reportPublic FDA data

Retrowash

Primary DI
25060485740012
Brand
Retrowash
Company
INTERMARK MEDICAL INNOVATIONS LIMITED
Model
RW46
Device description
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.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060485740012PackageGS12In Commercial Distribution
05060485740018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2506048574001225060485740012
05060485740018050604857400185060485740018

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage kit, surgicalA collection of sterile devices intended to be used during open colorectal surgery (bowel resection) to irrigate the colon above (proximal to) the site of a lesion/blockage, prior to surgical anastomosis, when preoperative preparation of the colon has not been possible, normally due to obstruction. The kit includes a nozzle (intended to be secured to the transected end of the colon above the lesion), an inflow tube, a waste tube, and may include a waste collection bag; it is intended to be connected to a gravity feed bag. The nozzle may also allow colonoscope access for intraoperative colonoscopy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter46Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801 571 2295customerservice@stonemountainsurgical.com

Regulatory Flags#

DUNS number
519829832
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060485740001RetrowashRW352023-06-09
05060485740018RetrowashRW462023-06-09
05060485740025ProctowashPR012023-06-09
25060485740005RetrowashRW352023-06-09
85060485740021ProctowashPR012023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091483ELMED INCORPORATEDELMED INCORPORATEDKOA2026-06-09
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
05996617000050UroDapter®/MID-IIPHARMICO MEDICAL Korlátolt Felelősségű TársaságKOA2025-08-25
00190776408459MillenniumAvalign Technologies, Inc.KOA2025-08-11
00190776408121MillenniumAvalign Technologies, Inc.KOA2025-08-06
00198506084416ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084430ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084447ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05