UNIFY PDO Surgical Sutures

GUDID 20814639022524

UNIFY PDO Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Rev Cut, 18"

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: 20814639022524
• NIH Device Record Key: ec3a616e-6c66-48b2-8fa6-c5f65dced86a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY PDO Surgical Sutures
• Version Model Number: M-D518R16
• 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	00814639022520 [Primary]
GS1	10814639022527 [Package]; Contains: 00814639022520; Package: box [12 Units]; In Commercial Distribution
GS1	20814639022524 [Package]; Contains: 10814639022527; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073614

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: 5
• Public Version Date: 2019-02-11
• Device Publish Date: 2016-11-09

On-Brand Devices [UNIFY PDO Surgical Sutures]

• 20814639022524: UNIFY PDO Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Rev Cut, 18"
• 20814639022517: UNIFY PDO Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Rev Cut, 18"
• 10814639020882: UNIFY PDO Surgical Sutures, Absorbable, XXL 1, 40mm 3/8 Circle Rev Cut, 30"
• 10814639020875: UNIFY PDO Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30"
• 10814639020868: UNIFY PDO Surgical Sutures, Absorbable, XL 0, 36mm 1/2 Circle Taper Pt, 30"
• 10814639020851: UNIFY PDO Surgical Sutures, Absorbable, XL 0, 30mm 3/8 Circle Rev Cut, 30"
• 10814639020844: UNIFY PDO Surgical Sutures, absorbable, 6-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639020837: UNIFY PDO Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639020820: UNIFY PDO Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639020813: UNIFY PDO Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639020806: UNIFY PDO Surgical Sutures, Absorbable, 4-0, 17mm 1/2 Circle Taper Point, 30"
• 10814639020790: UNIFY PDO Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 30"
• 10814639020783: UNIFY PDO Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639020776: UNIFY PDO Surgical Sutures, Absorbable, 3-0, 17mm 1/2 Circle Taper Point, 30"
• 10814639020769: UNIFY PDO Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 30"
• 10814639020752: UNIFY PDO Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639020745: UNIFY PDO Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30"
• 10814639020738: UNIFY PDO Surgical Sutures, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30"
• 10814639020721: UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 26mm 1/2 Circle Taper Pt, 30"
• 10814639020714: UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30"
• 10814639024316: UNIFY PDO Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639024309: UNIFY PDO Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639024293: UNIFY PDO Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639024286: UNIFY PDO Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639024279: UNIFY PDO Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639024262: UNIFY PDO Surgical Sutures, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" Undyed
• 10814639024255: UNIFY PDO Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30" Undyed
• 10814639024248: UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" Undyed
• 10814639024231: UNIFY PDO Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30" Undyed
• 10814639024118: UNIFY PDO Surgical Sutures, Absorbable, XXL Size 2, 40mm 3/8 Circle Rev Cut, 30"
• 10814639025917: UNIFY PDO Surgical Sutures, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" 3 Dzn.
• 10814639025900: UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" 3 DZN
• 10814639026129: UNIFY PDO Surgical Sutures, Absorbable, 2-0, 19mm 3/8 Circle Rev Cut, 30"