Proctowash

Basic Information

• Brand Name: Proctowash
• Primary DI: 05060485740025
• Version / Model: PR01
• Company Name: INTERMARK MEDICAL INNOVATIONS LIMITED
• Labeler DUNS: 519829832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 1
• Public Version Date: 2023-06-19
• Public Version Status: New
• Public Device Record Key: efce70e0-dd14-4264-81b1-8b60c72253a3

Device Description

Proctowash 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61327	Rectal medication applicator, single-use	A non-sterile instrument intended to be inserted into the rectum for the application of medication to treat local or systemic disease/conditions. It is a plastic device which may be in the form of a short tube to be connected to a cream medication tube, or a fluted tube with a plunger to administer a suppository. This is a single-use device.	No	Active
64507	Rectal medication/infusion catheter	A flexible tube intended to be inserted into the rectum (may be held in position by an inflatable retention balloon) for administration of a medication solution (e.g. opioids, anti-inflammatory, antibiotics) or infusion of hydration fluid; it may be retained short-term for multiple administrations. It may be supplied with additional disposable devices associated with insertion (e.g. syringe) or medication preparation (e.g., grinder). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	85060485740021	GS1		10	In Commercial Distribution
Primary	05060485740025	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]