COROLENE®

GUDID 13661522028367

PETERS SURGICAL

Polyolefin suture, monofilament
Primary Device ID13661522028367
NIH Device Record Keyb3f25d5f-8e3f-4d0b-8c42-3c3cbaa58ae2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOROLENE®
Version Model Number20S20BZ
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103661522028360 [Primary]
GS113661522028367 [Package]
Contains: 03661522028360
Package: [36 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAWSuture, nonabsorbable, synthetic, polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-13
Device Publish Date2020-01-04

On-Brand Devices [COROLENE®]

1366152204428220S35T
1366152204426820S10BT
1366152204425120S15CC
1366152204424420S15BV
1366152204422020S10BU
1366152204146520S20BH
1366152204119920N10Z
1366152204117520S20BC
1366152204101420S15BY
1366152204077220S20S
1366152204076520S20BF
1366152204073420S20BD
1366152203916520S20BB
1366152203912720S10BL
1366152203906620N10B
1366152203850220S35L
1366152203842720S10BJ
1366152203840320S15BT
1366152203814420P05AG
1366152203813720S20AB
1366152203797020S10BM
1366152203786420N15B
1366152203774120S15BQ
1366152203763520P15Z
1366152203762820S10BD
1366152203752920S15AW
1366152203746820S10AW
1366152203584620S15BP
1366152203581520P05U
1366152203399620S10AV
1366152203398920S30AM
1366152203396520S15BG
1366152203388020S10AU
1366152203343920S35J
1366152203321720S10S
1366152203320020S07X
1366152203317020S10AN
1366152203316320S15AY
1366152203271520N10I
1366152203263020S20AR
1366152203262320S20AT
1366152203249420S30AA
1366152203247020N10E
1366152203246320S15BC
1366152203240120S15X
1366152203086520S30AC
1366152203085820S05Q
1366152203082720S04J
1366152203074220S30AD
1366152203065020S20Q

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