Polyglycolic Acid (PGA) Sutures

GUDID 00616784913032

DYNAREX CORPORATION

Polyglycolic acid suture

• Primary Device ID: 00616784913032
• NIH Device Record Key: b9cb527f-c59e-4e12-aec1-ed0bdd185786
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polyglycolic Acid (PGA) Sutures
• Version Model Number: 9130
• 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	00616784913018 [Unit of Use]
GS1	00616784913025 [Primary]
GS1	00616784913032 [Package]; Contains: 00616784913025; Package: [25 Units]; In Commercial Distribution
GS1	00840117346390 [Package]; Contains: 00616784913018; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073614

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

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 [Polyglycolic Acid (PGA) Sutures]

• 00616784913230: 9132
• 00616784913131: 9131
• 00616784913032: 9130