UNIFY B-D218T36

GUDID 10814639025740

Knotless Barbed PDO Sutures with Stopper. 2/0, 18" 36mm Taper Pt 1/2 Cir, Pc.

APPLIED DENTAL, INC.

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 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: 10814639025740
• NIH Device Record Key: 3257deae-e9d1-4c63-8d4f-f744aef8099e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY
• Version Model Number: B-D218T36
• Catalog Number: B-D218T36
• 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: true
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639025743 [Primary]
GS1	10814639025740 [Package]; Contains: 00814639025743; Package: box [6 Units]; In Commercial Distribution
GS1	20814639025747 [Package]; Package: carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193209

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

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: 2022-02-28
• Device Publish Date: 2022-02-18

On-Brand Devices [UNIFY ]

• 10814639025764: Knotless Barbed PDO Sutures 3/0, 12" 19mm 3/8 Cir, Pc.
• 10814639025757: Knotless Barbed PDO Sutures with Stopper. 2/0, 18" 26mm Taper Pt 1/2 Cir, Pc.
• 10814639025740: Knotless Barbed PDO Sutures with Stopper. 2/0, 18" 36mm Taper Pt 1/2 Cir, Pc.