Renew Inserts

Basic Information

• Brand Name: Renew Inserts
• Primary DI: 00861680000427
• Version / Model: FG715
• Catalog Number: FG715
• Company Name: RENEW MEDICAL INC
• Labeler DUNS: 967228474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4cd609b2-9161-4bcf-9887-d25a3e297e2b

Device Description

Starter Pack of 5 individually packaged Renew Inserts consisting of 3 regular size and 2 large size single shot Inserts

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
PBP	Rectal Insert	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46193	Anal plug, single-use	A device designed to be inserted into the rectum by the user and retained there as a barrier to the passage of stool for the prevention of the involuntary evacuation of stool (faeces) in persons who are incontinent of bowel. It is typically made of plastic foam materials which expand upon contact with rectal moisture; it is available in a variety of sizes. The device may also be known as an anal tampon and is intended to be replaced after each rectal void. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861680000427	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122003	000