CARDIONYL®

GUDID 13661522006136

PETERS SURGICAL

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 13661522006136
• NIH Device Record Key: 8f809c49-66ae-4a91-86b7-b5f6c28d08a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIONYL®
• Version Model Number: 720252
• Company DUNS: 265741780
• Company Name: PETERS SURGICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661522006139 [Primary]
GS1	13661522006136 [Package]; Contains: 03661522006139; Package: [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913102

FDA Product Code

• GAR: Suture, nonabsorbable, synthetic, polyamide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-13
• Device Publish Date: 2020-01-04

On-Brand Devices [CARDIONYL®]

• 13661522010973: 72121K2
• 13661522009557: 72179K2
• 13661522009106: 72025
• 13661522009069: 721052
• 13661522008505: 72179
• 13661522007805: 721202
• 13661522007713: 722522
• 13661522007706: 72107
• 13661522007690: 72021
• 13661522007652: 722532
• 13661522007638: 721812
• 13661522007607: 72019NH23
• 13661522007591: 721792
• 13661522007584: 72106KH23
• 13661522007560: 72252
• 13661522007553: 721822
• 13661522007546: 721092
• 13661522007539: 720212
• 13661522007393: 722662
• 13661522007386: 721222
• 13661522007379: 721072
• 13661522007287: 72019LH28
• 13661522006921: 72020K2
• 13661522006167: 724032
• 13661522006150: 722542
• 13661522006143: 720502
• 13661522006136: 720252
• 13661522005948: 72487
• 13661522005924: 72448
• 13661522005917: 72413
• 13661522005900: 72401
• 13661522044459: 720292
• 13661522044435: 721292
• 13661522044305: 72020FH23M
• 13661522040994: 72177FH23
• 13661522038915: 72129FH23
• 13661522038908: 72029FH23
• 13661522038076: 72128FH23
• 13661522035174: 721272
• 13661522035167: 721242
• 13661522033149: 72123KH23
• 13661522028992: 72107K023
• 13661522028695: 72609
• 13661522028206: 720202H
• 13661522026981: 72189R
• 13661522026974: 72116R
• 13661522024925: 723402
• 13661522024376: 720202W
• 13661522024154: 72020K23M
• 13661522023829: 721772