GalaFLEX Scaffold GP013M

GUDID 00855920006102

GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months.

Tepha, Inc.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 00855920006102
• NIH Device Record Key: 559be5e9-1504-493b-84a0-6976c4cc97f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GalaFLEX Scaffold
• Version Model Number: 100035-19
• Catalog Number: GP013M
• Company DUNS: 039856765
• Company Name: Tepha, Inc.
• 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: false
• 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

Customer Support Contacts

• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com

Device Dimensions

• Length: 26 Centimeter
• Length: 26 Centimeter
• Width: 10.6 Centimeter
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• Length: 26 Centimeter
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• Length: 26 Centimeter
• Width: 10.6 Centimeter
• Length: 26 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855920006102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140533

FDA Product Code

• OOD: Surgical Film

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

[00855920006102]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-27

On-Brand Devices [GalaFLEX Scaffold]

• 00855920006133: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006126: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006119: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006102: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006096: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006089: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006072: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006065: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006058: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006041: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006034: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006027: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006010: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H
• 00855920006003: GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H