Silk Sutures

GUDID 00616784914336

DYNAREX CORPORATION

Silk suture, sterile Silk suture, sterile Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture

• 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