UNIFY PTFE Surgical Sutures M-F518R16

GUDID 10814639022237

PTFE Sutures, Non-absorbable, 5-0, monofilament, 16mm 3/8 circle Rev Cut, 18"

APPLIED DENTAL, INC.

Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament

• Primary Device ID: 10814639022237
• NIH Device Record Key: 53c03925-27d7-43d6-8920-83f01629d4e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFY PTFE Surgical Sutures
• Version Model Number: M-F518R16
• Catalog Number: M-F518R16
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639022230 [Primary]
GS1	10814639022237 [Package]; Contains: 00814639022230; Package: Box [12 Units]; In Commercial Distribution
GS1	20814639022234 [Package]; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170842

FDA Product Code

• NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [UNIFY PTFE Surgical Sutures]

• 20814639023699: PTFE Sutures, Non-absorbable, 6-0, monofilament, 13mm 3/8 circle Rev Cut, 18"
• 20814639023682: PTFE Sutures, Non-absorbable, 5-0, monofilament, 13mm 3/8 circle Rev Cut, 18"
• 20814639023675: PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 1/2 circle Taper Point, 18"
• 20814639023668: PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 3/8 circle Rev Cut, 18"
• 20814639023651: PTFE Sutures, Non-absorbable, 4-0, monofilament, 19mm 3/8 circle Rev Cut, 18"
• 20814639023644: PTFE Sutures, Non-absorbable, 4-0, monofilament, 16mm 3/8 circle Rev Cut, 18"
• 20814639023637: PTFE Sutures, Non-absorbable, 3-0, monofilament, 16mm 3/8 circle Rev Cut, 18"
• 20814639023620: PTFE Sutures, Non-absorbable, 3-0, monofilament, 19mm 3/8 circle Rev Cut, 18"
• 00814639023619: PTFE Sutures, Non-absorbable, 2-0, monofilament, 19mm 3/8 circle Rev Cut, 18"
• 10814639024859: PTFE Sutures, Non-absorbable, 3-0, monofilament, 50mm straight needle, 30"
• 10814639024842: PTFE Sutures, Non-absorbable, 2-0, monofilament, 60mm straight needle, 30"
• 10814639024057: PTFE Sutures, Non-absorbable, 2-0, monofilament, 36mm 1/2 circle Taper point, 30"
• 10814639022237: PTFE Sutures, Non-absorbable, 5-0, monofilament, 16mm 3/8 circle Rev Cut, 18"