GalaFLEX 3DR FR3D09

GUDID 00810054980070

GalaFLEX 3DR 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 ID00810054980070
NIH Device Record Key8c171870-9ce1-439d-ab75-7b0c64223107
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaFLEX 3DR
Version Model Number100043-09
Catalog NumberFR3D09
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

Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter
Length7.6 Centimeter
Height2.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810054980070 [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 3DR]

00810054980254GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980247GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980230GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980223GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980216GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980209GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980193GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980186GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980179GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980162GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980155GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980148GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980131GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00810054980124GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980117GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980100GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980094GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980087GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980070GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980063GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980056GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980049GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980032GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980025GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980018GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00810054980001GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty

Trademark Results [GalaFLEX 3DR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALAFLEX 3DR
GALAFLEX 3DR
88632114 not registered Live/Pending
Galatea Surgical, Inc.
2019-09-26

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