Silk Sutures

GUDID 00616784914336

DYNAREX CORPORATION

Silk suture, sterile

• Primary Device ID: 00616784914336
• NIH Device Record Key: 55eaceca-bf98-4e06-8a79-20c25fc964ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silk Sutures
• Version Model Number: 9143
• 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	00616784914312 [Unit of Use]
GS1	00616784914329 [Primary]
GS1	00616784914336 [Package]; Contains: 00616784914329; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080684

FDA Product Code

• GAP: Suture, Nonabsorbable, Silk

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Silk Sutures]

• 00616784914336: 9143
• 00616784914237: 9142