PGA RESOQUICK

GUDID E203USPR31104

Resorba Medical GmbH

Polyglycolic acid suture

• Primary Device ID: E203USPR31104
• NIH Device Record Key: 92a39161-c9ee-4d05-a199-51b52eec7c05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PGA RESOQUICK
• Version Model Number: PGA RESOQUICK
• Company DUNS: 341053195
• Company Name: Resorba Medical GmbH
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E203USPR31104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143584

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: 2
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-01-31

On-Brand Devices [PGA RESOQUICK]

• E203USPR31505: PGA RESOQUICK
• E203USPR31104: PGA RESOQUICK
• E203USPR30214: PGA RESOQUICK
• E203USPR30204: PGA RESOQUICK