UNIFY PGA Surgical Sutures

GUDID 20814639022876

UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Rev Cut, 18". Undyed.

APPLIED DENTAL, INC.

Polyglycolic acid suture

• Primary Device ID: 20814639022876
• NIH Device Record Key: 6109aa48-165b-4e09-84f2-d50665056773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY PGA Surgical Sutures
• Version Model Number: M-G418R16-U
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639022872 [Primary]
GS1	10814639022879 [Package]; Contains: 00814639022872; Package: box [12 Units]; In Commercial Distribution
GS1	20814639022876 [Package]; Contains: 10814639022879; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073614

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-09

On-Brand Devices [UNIFY PGA Surgical Sutures]

• 20814639022890: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Rev Cut, 18". Undyed.
• 20814639022883: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Rev Cut, 18"
• 20814639022876: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Rev Cut, 18". Undyed.
• 20814639022869: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Rev Cut, 18"
• 20814639022562: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Conventional Cut, 18". Undyed.
• 20814639022555: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Conventional Cut, 18". Undyed.
• 20814639022548: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Conventional Cut, 18"
• 20814639022531: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Conventional Cut, 18"
• 10814639021650: UNIFY PGA Surgical Sutures, Size 8-0, Braided Coated, 6.4mm 3/8 Cir Spatula, Double, 12"
• 10814639021643: UNIFY PGA Surgical Sutures, Size 6-0, Braided Coated, 6.4mm 3/8 Cir Spatula, Double, 12"
• 10814639021636: UNIFY PGA Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30". Violet.
• 10814639021629: UNIFY PGA Surgical Sutures, Absorbable, XS, 7-0, 11mm 3/8 Circle Rev Cut, 18" Violet
• 10814639021612: UNIFY PGA Surgical Sutures, Absorbable, XS, 6-0, 11mm 3/8 Circle Rev Cut, 18" Undyed.
• 10814639021605: UNIFY PGA Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30" Undyed.
• 10814639021599: UNIFY PGA Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30"
• 10814639021582: UNIFY PGA Surgical Sutures, Absorbable, XL 0, 36mm 1/2 Circle Taper Pt, 30"
• 10814639021575: UNIFY PGA Surgical Sutures, Absorbable, XL 0, 30mm 3/8 Circle Rev Cut, 30"
• 10814639021131: UNIFY PGA Surgical Sutures, Absorbable, 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639021124: UNIFY PGA Surgical Sutures, Absorbable, 6-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639021117: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639021100: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639021094: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639021087: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639021070: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639021063: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639021056: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 17mm 1/2 Circle Taper Pt, 30". Undyed
• 10814639021049: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 17mm 1/2 Circle Taper Pt, 30"
• 10814639021032: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 30"
• 10814639021025: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639021018: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639021001: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 17mm 1/2 Circle Taper Pt, 30"
• 10814639020998: UNIFY PGA Surgical Sutures,Absorbable, 3-0, 17mm 1/2 Circle Taper Pt, 30". Undyed
• 10814639020981: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 30"
• 10814639020974: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18", Undyed
• 10814639020967: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639020950: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30". Undyed
• 10814639020943: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30"
• 10814639020936: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 24mm 3/8 Circle Rev Cut, 30". Undyed
• 10814639020929: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 24mm 3/8 Circle Rev Cut, 30"
• 10814639020912: UNIFY PGA Surgical Sutures, Absorbable, 2-0, 26mm 1/2 Circle Taper Pt, 30". Undyed
• 10814639020905: UNIFY PGA Surgical Sutures, Absorbable, LG 2-0, 26mm 1/2 Circle Taper Pt, 30"
• 10814639020899: UNIFY PGA Surgical Sutures Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30"
• 10814639025511: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed
• 10814639025597: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Cir, R/C Violet, 18"3 DZN Pack
• 30814639025294: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Cir R/C, 18" Undyed 3 DZN Pack
• 10814639025603: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed, 1 of 36
• 10814639025771: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed. 1 of 36
• 10814639025627: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18" Violet. 1 pc of 36
• 10814639023364: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, Violet. 18" of 36
• 10814639023357: UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18", Undyed. 1 of 36.