Premium UNIFY PP Sutures

GUDID 20814639022425

Premium Polypropylene, Med 4-0, 19mm 3/8 circle Rev Cut, 18"

APPLIED DENTAL, INC.

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 20814639022425
• NIH Device Record Key: 9e9ef7f8-b145-47f9-a194-ace9a6d7e061
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium UNIFY PP Sutures
• Version Model Number: PMP-418R19
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639022421 [Primary]
GS1	10814639022428 [Package]; Contains: 00814639022421; Package: box [12 Units]; In Commercial Distribution
GS1	20814639022425 [Package]; Contains: 10814639022428; 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: 2016-11-09

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• 20814639022432: Premium Polypropylene, Sm 4-0, 13mm 3/8 circle Rev Cut, 18"
• 20814639022425: Premium Polypropylene, Med 4-0, 19mm 3/8 circle Rev Cut, 18"
• 20814639022418: Premium Polypropylene, Med 5-0, 19mm 3/8 circle Rev Cut, 18"
• 10814639021957: Premium Polypropylene, Sm 5-0, 13mm 3/8 circle Rev Cut, 18"
• 10814639024798: Premium Polypropylene, Med 3-0, 19mm 3/8 circle Rev Cut, 18"
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• 10814639023739: Premium Polypropylene, 4-0, 24mm 3/8 circle Rev Cut, 27"