Polypropylene Sutures

GUDID 00616784911830

DYNAREX CORPORATION

Polyolefin suture, monofilament

• Primary Device ID: 00616784911830
• NIH Device Record Key: b93e95b1-6e63-45b1-a5f1-8572139c8b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polypropylene Sutures
• Version Model Number: 9118
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 12
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784911816 [Unit of Use]
GS1	00616784911823 [Primary]
GS1	00616784911830 [Package]; Contains: 00616784911823; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080684

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: 2016-09-24

On-Brand Devices [Polypropylene Sutures]

• 00616784912035: 9120
• 00616784911939: 9119
• 00616784911830: 9118
• 00616784911731: 9117