Premium UNIFY PGCL Surgical Sutures

GUDID 10814639024873

Premium PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 27" Undyed.

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 10814639024873
• NIH Device Record Key: d008c59f-7b42-49a5-b2ab-e3122ab009de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium UNIFY PGCL Surgical Sutures
• Version Model Number: PMQ-327R19
• 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
• 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	00814639024876 [Primary]
GS1	10814639024873 [Package]; Contains: 00814639024876; Package: Box [12 Units]; In Commercial Distribution
GS1	20814639024870 [Package]; Package: Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130737

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

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: 2020-08-12
• Device Publish Date: 2020-08-04

On-Brand Devices [Premium UNIFY PGCL Surgical Sutures]

• 20814639023828: Premium PGCL, LG 3-0, 24mm 3/8 Circle Rev Cut, 27". Violet.
• 10814639023814: Premium PGCL, LG 4-0, 24mm 3/8 Circle Rev Cut, 27". Violet
• 30814639023016: Premium PGCL, Absorbable, Sm, 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
• 20814639023002: Premium PGCL, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
• 20814639022999: Premium PGCL, Absorbable, Sm, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
• 20814639022982: Premium PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
• 20814639022975: Premium PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
• 20814639022968: Premium PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
• 00814639024326: Premium PGCL, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Violet
• 20814639024931: Premium PGCL, Absorbable, Sm, 5-0, 13mm 1/2 circle Taper Pt, 18" Undyed.
• 10814639024873: Premium PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 27" Undyed.
• 10814639025283: Premium PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
• 10814639025276: Premium PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
• 10814639024460: Premium PGCL, Absorbable, Sm, 4-0, 13mm 3/8 Circle Rev Cut, 18" Violet Color
• 10814639026112: Premium PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
• 10814639026105: Premium PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 27" Undyed.
• 10814639026099: Premium PGCL, LG 4-0, 24mm 3/8 Circle Rev Cut, 27". Undyed.
• 10814639026082: Premium PGCL, LG 3-0, 24mm 3/8 Circle Rev Cut, 27". Undyed.
• 10814639026075: Premium PGCL, LG 2-0, 24mm 3/8 Circle Rev Cut, 27". Undyed.