GalaFLEX Scaffold GP016S

GUDID 00855920006058

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 ID00855920006058
NIH Device Record Keyb903e528-c689-469e-bd99-a775d1a9ff35
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaFLEX Scaffold
Version Model Number100035-23
Catalog NumberGP016S
Company DUNS039856765
Company NameTepha, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com

Device Dimensions

Length22 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter
Width10 Centimeter
Length22 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100855920006058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OODSurgical Film

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

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Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

[00855920006058]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-27

On-Brand Devices [GalaFLEX Scaffold]

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