Renew Inserts FG715

GUDID 00861680000427

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

RENEW MEDICAL INC

Anal plug, single-use
Primary Device ID00861680000427
NIH Device Record Key4cd609b2-9161-4bcf-9887-d25a3e297e2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRenew Inserts
Version Model NumberFG715
Catalog NumberFG715
Company DUNS967228474
Company NameRENEW MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-987-2929
Emailricky@renew-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861680000427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBPRectal Insert

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-01

On-Brand Devices [Renew Inserts]

1086747600004330 pack carton of individually packaged Renew large size Inserts
1086747600003630 pack carton of individually packaged Renew regular size Inserts
10867476000029Starter Pack of 10 individually packaged Renew Inserts consisting of 5 regular size and 5 large
00861680000427Starter Pack of 5 individually packaged Renew Inserts consisting of 3 regular size and 2 large
0086168000041030 pack carton of individually packaged Renew large size single shot Inserts
0086168000040330 pack carton of individually packaged Renew regular size single shot Inserts

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