OPTIME R

GUDID 03661522020937

PETERS SURGICAL

Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Primary Device ID03661522020937
NIH Device Record Key143a04d4-54a7-444e-8ff8-184d21afcfc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTIME R
Version Model Number12S20C
Company DUNS265741780
Company NamePETERS SURGICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103661522020937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-17
Device Publish Date2025-01-09

On-Brand Devices [OPTIME R]

0366152210023312S15T
0366152204458212S10G
0366152204374512S40N
0366152204373812S40P
0366152204139012S20L
0366152204138312S30N
0366152203783612S20Q
0366152203781212S15R
0366152203364712D10A
0366152203348712S40H
0366152203297812N20G
0366152203296112N15G
0366152203072112S40F
0366152203070712S20K
0366152202971812S35H
0366152202909112S30J
0366152202908412S40C
0366152202886512S15H
0366152202874212S35F
0366152202873512S40D
0366152202735612S35G
0366152202734912S30G
0366152202637312S30F
0366152202602112S30AL
0366152202388412S35E
0366152202108812S40B
0366152202107112S40A
0366152202106412S35D
0366152202105712S35C
0366152202104012S35B
0366152202103312S35A
0366152202102612S30E
0366152202101912S30D
0366152202100212S30C
0366152202099912S30B
0366152202098212S30A
0366152202097512S20G
0366152202096812S20F
0366152202095112S20E
0366152202094412S20D
0366152202093712S20C
0366152202092012S20B
0366152202091312S20A
0366152202090612S15G
0366152202089012S15F
0366152202088312S15E
0366152202087612S15D
0366152202086912S15C
0366152202085212S15B
0366152202084512S15A

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.