FDA.reportPublic FDA data

Renew Inserts

Primary DI
00861680000427
Brand
Renew Inserts
Company
RENEW MEDICAL INC
Model
FG715
Catalog number
FG715
Device description
Starter Pack of 5 individually packaged Renew Inserts consisting of 3 regular size and 2 large size single shot Inserts
Published
2017-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBPRectal Insert

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBPRectal InsertGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122003000RENEW INSERTRenew Medical, Inc.2012-10-26PBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861680000427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861680000427008616800004278616800004270861680000427

GMDN Terms#

Term, Definition table
TermDefinition
Anal plug, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-987-2929ricky@renew-medical.com

Regulatory Flags#

DUNS number
967228474
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861680000458Navina Inserts69301693012019-01-18
00861680000465Navina Inserts69302693022019-01-18
00861680000472Navina Inserts69303693032019-01-18
00867476000022Renew Inserts7027022016-09-16
00867476000039Renew Inserts7067062016-09-16
00867476000046Renew Inserts7077072016-09-16
00861680000403Renew InsertsFG730FG7302017-10-01
00861680000410Renew InsertsFG731FG7312017-10-01
10867476000029Renew Inserts7027022016-09-16
10867476000036Renew Inserts7067062016-09-16
10867476000043Renew Inserts7077072016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00865453000331StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000348StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000362StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000379StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000324StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000355StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000300StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000317StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00861680000458Navina InsertsRENEW MEDICAL INCPBP2019-01-18
00861680000465Navina InsertsRENEW MEDICAL INCPBP2019-01-18
00861680000472Navina InsertsRENEW MEDICAL INCPBP2019-01-18
00861680000403Renew InsertsRENEW MEDICAL INCPBP2017-10-01
00861680000410Renew InsertsRENEW MEDICAL INCPBP2017-10-01
00867476000022Renew InsertsRENEW MEDICAL INCPBP2016-09-16
00867476000039Renew InsertsRENEW MEDICAL INCPBP2016-09-16
00867476000046Renew InsertsRENEW MEDICAL INCPBP2016-09-16
10867476000029Renew InsertsRENEW MEDICAL INCPBP2016-09-16
10867476000036Renew InsertsRENEW MEDICAL INCPBP2016-09-16
10867476000043Renew InsertsRENEW MEDICAL INCPBP2016-09-16