Nylon Sutures

GUDID 00616784910338

DYNAREX CORPORATION

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 00616784910338
• NIH Device Record Key: 7c2a5a94-2c6b-4a70-b383-cebb2b3d0425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nylon Sutures
• Version Model Number: 9103
• 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	00616784910314 [Unit of Use]
GS1	00616784910321 [Primary]
GS1	00616784910338 [Package]; Contains: 00616784910321; Package: [25 Units]; In Commercial Distribution
GS1	00840117346345 [Package]; Contains: 00616784910314; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080684

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

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 [Nylon Sutures]

• 00616784910734: 9107
• 00616784910635: 9106
• 00616784910536: 9105
• 00616784910437: 9104
• 00616784910338: 9103
• 00616784910239: 9102
• 00616784910130: 9101
• 00616784910031: 9100