Premium UNIFY PDO Sutures

GUDID 20814639023835

Premium PDO Suture, Size 4-0, 24mm 3/8 Cir Rev Cut, Violet, 27"

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 20814639023835
• NIH Device Record Key: 3f44bab9-1b28-417d-ac57-63b640c7cad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium UNIFY PDO Sutures
• Version Model Number: PLD-427R24
• Company DUNS: 017524666
• Company Name: APPLIED DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639023831 [Primary]
GS1	10814639023838 [Package]; Contains: 00814639023831; Package: box [12 Units]; In Commercial Distribution
GS1	20814639023835 [Package]; Contains: 10814639023838; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022666

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-08-13

On-Brand Devices [Premium UNIFY PDO Sutures]

• 20814639023842: Premium PDO, Med 3-0, 19mm 3/8 Cir Rev Cut, Violet, 18"
• 20814639023835: Premium PDO Suture, Size 4-0, 24mm 3/8 Cir Rev Cut, Violet, 27"
• 20814639023774: Premium PDO Suture, Size 3-0, 24mm 3/8 Cir Rev Cut, Violet, 27"
• 20814639022715: Premium UNIFY PDO Sutures, Sm 6-0, 13mm 3/8 circle Rev Cut, 18"
• 20814639022708: Premium UNIFY PDO Sutures, Sm 5-0, 13mm 3/8 circle Rev Cut, 18"
• 20814639022692: Premium UNIFY PDO Sutures, Sm 4-0, 13mm 3/8 circle Rev Cut, 18"
• 20814639022685: Premium UNIFY PDO Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18"
• 20814639022678: Premium UNIFY PDO Sutures, Med 4-0, 19mm 3/8 circle Rev Cut, 18"
• 20814639022661: Premium UNIFY PDO Sutures, Med 5-0, 16mm 3/8 circle Rev Cut, 18"
• 20814639022654: Premium UNIFY PDO Sutures, Med 4-0, 16mm 3/8 circle Rev Cut, 18"
• 10814639023272: Premium PDO, Med 2-0, 19mm 3/8 Cir Rev Cut, Violet, 18"
• 10814639025993: Premium PDO, Med 4-0, 19mm 3/8 Cir Rev Cut, Violet, 27"
• 10814639025986: Premium PDO, Med 3-0, 19mm 3/8 Cir Rev Cut, Violet, 27"
• 10814639025979: Premium PDO, Med 2-0, 19mm 3/8 Cir Rev Cut, Violet, 27"
• 10814639025962: Premium PDO Suture, Size 2-0, 24mm 3/8 Cir Rev Cut, Violet, 27"