PGA RESOQUICK

GUDID E203USPR31505

Resorba Medical GmbH

Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture

• Primary Device ID: E203USPR31505
• NIH Device Record Key: 881fbfc9-0261-44d9-96dd-285038667c3b
• 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	E203USPR31505 [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