GalaFLEX 3D SH3D07

GUDID 00810054980322

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made 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.

Tepha, Inc.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID00810054980322
NIH Device Record Key8b95215f-3c56-4a66-bea4-4cd43d913328
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaFLEX 3D
Version Model Number100042-07
Catalog NumberSH3D07
Company DUNS039856765
Company NameTepha, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Device Dimensions

Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter
Width20.3 Centimeter
Length7.6 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810054980322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OODSurgical Film

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-07
Device Publish Date2020-09-29

On-Brand Devices [GalaFLEX 3D]

00810054980537GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980520GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980513GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980506GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980490GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980483GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980476GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980469GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980452GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980445GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980438GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980421GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980414GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980407GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980391GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980384GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980377GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980360GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980353GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980346GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980339GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980322GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980315GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980308GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980292GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980285GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980278GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980261GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr

Trademark Results [GalaFLEX 3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALAFLEX 3D
GALAFLEX 3D
88632099 not registered Live/Pending
Galatea Surgical, Inc.
2019-09-26

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