GalaFLEX Scaffold GP019S

GUDID 00855920006072

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	00855920006072
NIH Device Record Key	49b3cda4-5810-4abc-af12-3aa5a6dc8f1f
Commercial Distribution Status	In Commercial Distribution
Brand Name	GalaFLEX Scaffold
Version Model Number	100035-29
Catalog Number	GP019S
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

Device Dimensions

Length	14 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter
Width	7.7 Centimeter
Length	14 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855920006072 [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

[00855920006072]

Ethylene Oxide

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[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

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[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

Ethylene Oxide

[00855920006072]

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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