UNIFY PP Surgical Sutures

GUDID 20814639022586

Polypropylene, Non-absorbable 5-0, 16mm 3/8 Cir Rev Cut, 18" Dyed.

APPLIED DENTAL, INC.

Polyolefin suture, monofilament

• Primary Device ID: 20814639022586
• NIH Device Record Key: 27f9e1c4-558f-4041-87c7-59ee7b5a124d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY PP Surgical Sutures
• Version Model Number: M-P518R16
• 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	00814639022582 [Primary]
GS1	10814639022589 [Package]; Contains: 00814639022582; Package: box [12 Units]; In Commercial Distribution
GS1	20814639022586 [Package]; Contains: 10814639022589; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000537

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-11-10

On-Brand Devices [UNIFY PP Surgical Sutures]

• 20814639023347: Polypropylene Suture, Non-absorbable, Size 2/0, 24mm Reverse Cut Needle, 30".
• 20814639023316: Polypropylene Suture, Non-absorbable, Size 0, 36mm Taper Point Needle, 30".
• 20814639023286: Polypropylene Suture, Non-absorbable, Size 2, 40mm Taper Point Needle, 30".
• 20814639023224: Polypropylene Suture, Non-absorbable 2/0,60mm Straight Cutting needle, 30".
• 20814639022586: Polypropylene, Non-absorbable 5-0, 16mm 3/8 Cir Rev Cut, 18" Dyed.
• 20814639022579: Polypropylene, Nonbsorbable 4-0, 16mm 3/8 Cir Rev Cut, 18" Dyed.
• 10814639021940: Polypropylene, Nonbsorbable 7-0, 11mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639021933: Polypropylene, Nonbsorbable 6-0, 11mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639021926: Polypropylene, Nonbsorbable 6-0, 13mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639021919: Polypropylene, Nonbsorbable 5-0, 13mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639021902: Polypropylene, Nonbsorbable 4-0, 13mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639021896: Polypropylene, Nonbsorbable 5-0,19mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639021889: Polypropylene, Nonabsorbable 4-0,19mm 3/8 Cir Rev Cut, 30" Blue.
• 10814639021872: Polypropylene, Nonbsorbable 4-0, 19mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639021865: Polypropylene, Nonabsorbable 3-0,19mm 3/8 Cir Rev Cut, 30" Blue.
• 10814639021858: Polypropylene, Nonabsorbable 3-0, 19mm 3/8 Cir Rev Cut, 18" Blue.
• 10814639025894: Polypropylene, Nonabsorbable 6-0, 13mm 3/8 Cir Rev Cut, 18" Blue.3 DZN
• 10814639025887: Polypropylene, Nonabsorbable 5-0, 13mm 3/8 Cir Rev Cut, 18" Blue. 3 Dzn.
• 10814639025870: Polypropylene, Nonabsorbable 4-0, 13mm 3/8 Cir Rev Cut, 18" Blue. 3 Dzn
• 10814639025863: Polypropylene, Nonabsorbable 4-0, 19mm 3/8 Cir Rev Cut, 18" Blue. 3 dzn.