UNIFY Chromic Gut Surgical Sutures

GUDID 10814639026594

UNIFY Chromic Gut Surgical Sutures, 5-0, 16mm 3/8 Cir Reverse Cut, 18". 12 pcs/box.

APPLIED DENTAL, INC.

Catgut suture, chromic

• Primary Device ID: 10814639026594
• NIH Device Record Key: 29a5d338-204a-450e-a514-2681804f60bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY Chromic Gut Surgical Sutures
• Version Model Number: M-C518R16
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639026597 [Primary]
GS1	10814639026594 [Package]; Contains: 00814639026597; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072930

FDA Product Code

• GAL: Suture, Absorbable, Natural

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: 2025-06-27
• Device Publish Date: 2025-06-19

On-Brand Devices [UNIFY Chromic Gut Surgical Sutures]

• 1081463902131: Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27"
• 10814639021308: Chromic Gut, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639021292: UNIFY Chromic Gut Surgical Sutures, XL 2-0, 36mm 1/2 Cir Taper point, 27"
• 10814639021315: Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27"
• 10814639026600: Chromic Gut, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18"
• 10814639026594: UNIFY Chromic Gut Surgical Sutures, 5-0, 16mm 3/8 Cir Reverse Cut, 18". 12 pcs/box.
• 10814639026587: UNIFY Chromic Gut Surgical Sutures, 4-0, 16mm 3/8 Cir Reverse Cut, 18". 12 pcs/box.
• 10814639026563: UNIFY Chromic Gut Surgical Sutures, 3-0, 19mm 3/8 Cir Reverse Cut, 18". 12 pcs/box.