UNIFY Silk Surgical Sutures

GUDID 20814639022630

Silk, Med 4-0, 16mm 3/8 Circle Rev Cut, 18"

APPLIED DENTAL, INC.

Silk suture, sterile Silk suture, sterile Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture

• Primary Device ID: 20814639022630
• NIH Device Record Key: 17477d37-cf27-47f4-8afc-839b46f499ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY Silk Surgical Sutures
• Version Model Number: M-S418R16
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639022636 [Primary]
GS1	10814639022633 [Package]; Contains: 00814639022636; Package: box [12 Units]; In Commercial Distribution
GS1	20814639022630 [Package]; Contains: 10814639022633; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080684

FDA Product Code

• GAP: Suture, Nonabsorbable, Silk

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 Silk Surgical Sutures]

• 20814639023163: UNIFY Silk Sutures, XXL 2-0/30", 60mm Straight Cutting
• 20814639023132: UNIFY Silk Sutures, XXL 3-0/30", 60mm Straight Cutting
• 20814639022647: Silk, Med 5-0, 16mm 3/8 Circle Rev Cut, 18"
• 20814639022630: Silk, Med 4-0, 16mm 3/8 Circle Rev Cut, 18"
• 10814639020677: Silk, Small 6-0 13mm 3/8 Circle Rev Cut, 18"
• 10814639020660: Silk, Small 5-0 13mm 3/8 Circle Rev Cut, 18"
• 10814639020653: Silk, Small 4-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639020646: Silk, Med 5-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639020639: Silk, Med 4-0/30", 19mm 3/8 Circle Rev Cut
• 10814639020622: Silk, Med 4-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639020615: Silk, Med 3-0/30", 19mm 3/8 Circle Rev Cut
• 10814639020608: Silk, Med 3-0, 19mm 3/8 Circle Rev Cut, 18"
• 10814639020295: UNIFY Silk Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30"