Premium UNIFY PGLA Sutures

GUDID 10814639023883

Premium PGLA Suture, Size 1, 40mm 1/2 Cir Taper Point, Undyed. 27"

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, multifilament

• Primary Device ID: 10814639023883
• NIH Device Record Key: 93398c71-a086-44be-b2f1-e2c3cbdd32f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium UNIFY PGLA Sutures
• Version Model Number: PXXLU-1G27T40
• 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: true
• 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
• 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	00814639023886 [Primary]
GS1	10814639023883 [Package]; Contains: 00814639023886; Package: box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073614
• Premarket Notification: K161629

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: 2
• Public Version Date: 2019-07-15
• Device Publish Date: 2018-08-13

On-Brand Devices [Premium UNIFY PGLA Sutures]

• 10814639023920: Premium PGLA Suture, Size 2/0, 40mm 1/2 Cir Taper Point, Undyed, 27"
• 10814639023913: Premium PGLA Suture, Size 2/0, 40mm 1/2 Cir Taper Point, Violet, 27"
• 10814639023906: Premium PGLA Suture, Size 0, 40mm 1/2 Cir Taper Point, Undyed, 27"
• 10814639023890: Premium PGLA Suture, Size 0, 40mm 1/2 Cir Taper Point, Violet, 27"
• 10814639023883: Premium PGLA Suture, Size 1, 40mm 1/2 Cir Taper Point, Undyed. 27"
• 20814639023804: Premium PGLA, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" Violet.
• 20814639023798: Premium PGLA, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
• 20814639023781: Premium PGLA Suture, Size 4-0, 24mm 3/8 Cir Rev Cut, Violet, 27"
• 20814639023767: Premium PGLA Suture, Size 3-0, 24mm 3/8 Cir Rev Cut, Violet, 27"