Premium UNIFY PP Sutures

GUDID 20814639022432

Premium Polypropylene, Sm 4-0, 13mm 3/8 circle Rev Cut, 18"

APPLIED DENTAL, INC.

Polyolefin suture, monofilament

• Primary Device ID: 20814639022432
• NIH Device Record Key: a2d3ccae-d9e5-4623-8890-c38e5c19fb91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium UNIFY PP Sutures
• Version Model Number: PSP-418R13
• 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	00814639022438 [Primary]
GS1	10814639022435 [Package]; Contains: 00814639022438; Package: box [12 Units]; In Commercial Distribution
GS1	20814639022432 [Package]; Contains: 10814639022435; 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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• 20814639022418: Premium Polypropylene, Med 5-0, 19mm 3/8 circle Rev Cut, 18"
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• 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"