UNIFY Nylon Surgical Sutures

GUDID 20814639023590

Nylon Surgical Biopsy Sutures , 4-0, 13mm 3/8 circle Rev Cut, 10"

APPLIED DENTAL, INC.

Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 20814639023590
• NIH Device Record Key: bb82d880-2942-42e0-8114-f4822d02286a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY Nylon Surgical Sutures
• Version Model Number: S-N410R13-B
• 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	00814639023596 [Primary]
GS1	10814639023593 [Package]; Contains: 00814639023596; Package: bx [12 Units]; In Commercial Distribution
GS1	20814639023590 [Package]; Contains: 10814639023593; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080684

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

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: 2017-07-25

On-Brand Devices [UNIFY Nylon Surgical Sutures]

• 20814639023606: UNIFY Nylon Surgical Sutures, XXS 10-0, 6.5mm 3/8 circle Rev Cut, 7"
• 20814639023590: Nylon Surgical Biopsy Sutures , 4-0, 13mm 3/8 circle Rev Cut, 10"
• 20814639023255: Nylon Sutures, Size 2, 40mm Taper Point, 30".
• 20814639023194: Nylon Sutures, 2/0, 60mm Straight Cutting, 30".
• 20814639022616: Nylon, 5-0, 16mm 3/8 circle Rev Cut, 18"
• 40814639022603: Nylon, 4-0, 16mm 3/8 circle Rev Cut, 18"
• 10814639021674: UNIFY Nylon Surgical Sutures
• 10814639021667: UNIFY Nylon Surgical Sutures, Size10-0, 6.4mm 3/8 Circle Spatula Double Micro-Needle, 12"
• 10814639020288: UNIFY Nylon Surgical Sutures, XS 6-0, 11mm 3/8 circle Rev Cut, 18"
• 10814639020271: UNIFY Nylon Surgical Sutures, XL 2-0, 36mm 1/2 Cir Taper Pt, 30"
• 10814639020264: UNIFY Nylon Surgical Sutures, XL 0, 36mm 1/2 Cir Taper Pt, 30"
• 10814639020257: UNIFY Nylon Surgical Sutures, XL 0, 30mm 3/8 circle Rev Cut, 30"
• 10814639020240: Nylon Surgical Biopsy Sutures, 6-0, 13mm 3/8 circle Rev Cut, 10"
• 10814639020233: Nylon Surgical Sutures, 6-0, 13mm 3/8 circle Rev Cut, 18"
• 10814639020226: Nylon Surgical Biopsy Sutures , 5-0, 13mm 3/8 circle Rev Cut, 10"
• 10814639020219: Nylon Suture, 5-0, 13mm 3/8 circle Rev Cut, 18"
• 10814639020202: Nylon, 4-0, 13mm 3/8 circle Rev Cut, 18"
• 10814639020196: Nylon, 5-0, 19mm 3/8 circle Rev Cut, 18"
• 10814639020189: Nylon Biopsy, 5-0, 19mm 3/8 circle Rev Cut, 10"
• 10814639020172: Nylon, 4-0, 19mm 3/8 circle Rev Cut, 30"
• 10814639020165: Nylon, 4-0, 19mm 3/8 circle Rev Cut, 18"
• 10814639020158: Nylon Biopsy, 4-0, 19mm 3/8 circle Rev Cut, 10"
• 10814639020141: Nylon, 3-0, 19mm 3/8 circle Rev Cut, 30"
• 10814639024149: UNIFY Nylon Ultra-Premium Microsutures , XXS 10-0, 4mm taper Point, 5"
• 10814639024132: UNIFY Nylon Ultra-Premium Microsutures , XXS 9-0, 5mm taper Point, 5"
• 10814639024125: Ultra-Premium Microsutures Nylon Size 7.0 Spatula needle, 13mm, 18".
• 10814639025665: Nylon Surgical Sutures, 6-0, 13mm 3/8 circle Rev Cut, 18" 3 DZN Pack
• 10814639025658: Nylon Suture, 5-0, 13mm 3/8 circle Rev Cut, 18" 3 DZN Pack
• 10814639025634: Nylon, 5-0, 19mm 3/8 circle Rev Cut, 18" 3 DZN Pack
• 10814639025610: Nylon, 4-0, 19mm 3/8 circle Rev Cut, 18" 3 DZN Pack
• 10814639023333: Nylon Sutures, 4-0, 13mm 3/8 circle Rev Cut, 18". Black. 1 Pc of the 3 Dzn.
• 10814639023326: Nylon Biopsy Sutures , 4-0, 19mm 3/8 circle Rev Cut, 10" Black. 1 pc of 36