UNIFY PGCL Surgical Sutures

GUDID 10814639025535

PGCL, Absorbable, XS, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed.

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 10814639025535
• NIH Device Record Key: 92ffb00b-8d58-4730-ab29-c39285d573c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY PGCL Surgical Sutures
• Version Model Number: XS-Q518R11
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639025538 [Primary]
GS1	10814639025535 [Package]; Contains: 00814639025538; Package: Box [12 Units]; In Commercial Distribution
GS1	20814639025532 [Package]; Package: Case [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: 2021-05-03
• Device Publish Date: 2021-04-23

On-Brand Devices [UNIFY PGCL Surgical Sutures]

• 20814639022500: PGCL, Absorbable, Med, 5-0, 16mm 3/8 Circle, Conventional Cut, 18" Undyed.
• 20814639022494: PGCL, Absorbable, Med, 4-0, 16mm 3/8 Circle, Conventional Cut, 18" Undyed.
• 10814639022404: PGCL Suture, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color.
• 10814639022343: PGCL Suture, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color.
• 10814639022336: PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
• 10814639022312: PGCL Sutures, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Violet Color.
• 10814639021841: PGCL, Absorbable, Size 1, 40mm 1/2 Circle Taper Pt, 30" Undyed.
• 10814639021834: PGCL, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30" Undyed.
• 10814639021827: PGCL, Absorbable, XL 0, 36mm 1/2 Circle Taper Pt, 30" Undyed.
• 10814639021810: PGCL, Absorbable, Sm, 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
• 10814639021803: PGCL, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
• 00814639021783: PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
• 10814639021773: PGCL, Absorbable, Med, 4-0, 17mm 1/2 Circle Taper Point, 30" Undyed.
• 10814639021766: PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 30" Undyed.
• 10814639021759: PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
• 10814639021742: PGCL, Absorbable, Med, 3-0, 17mm 1/2 Circle Taper Point, 30"
• 10814639021735: PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 30" Undyed.
• 10814639021728: PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
• 10814639021711: PGCL, Absorbable, LG 3-0, 26mm 1/2 Circle Taper Pt, 30" Undyed.
• 10814639021704: PGCL, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" Undyed.
• 10814639021698: PGCL, Absorbable, LG 2-0, 26mm 1/2 Circle Taper Pt, 30" Undyed.
• 10814639021681: PGCL, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" Unded.
• 10814639025542: PGCL, Absorbable, XS, 5-0, 11mm 3/8 Circle Rev Cut, 18" Violet
• 10814639025535: PGCL, Absorbable, XS, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed.
• 00814639025835: PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" violet. 3 Dzn.
• 10814639025825: PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.3 Dzn.
• 10814639025818: PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 30" Undyed.3 Dzn.
• 10814639025801: PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.3 Dzn.
• 10814639025795: PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 30" Undyed.3 Dzn.
• 10814639026167: PGCL, Absorbable, LG 4-0, 24mm 3/8 Circle Rev Cut, 30" Undyed.
• 10814639025931: PGCL Sutures, Absorbable, Sm, 6-0, 13mm 3/8 Circle Rev Cut, 18" Violet Color.