GalaFLEX CE0208

GUDID 00855920006584

GalaFLEX 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 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 ID00855920006584
NIH Device Record Key1a8f5dd4-ea3a-4c65-8a40-0d8efd73401d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaFLEX
Version Model Number100035-35
Catalog NumberCE0208
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

Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com
Phone7813571750
Emailcontact@galateasurgical.com

Device Dimensions

Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter
Height5 Centimeter
Length20 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100855920006584 [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 Date2020-08-26
Device Publish Date2020-08-18

On-Brand Devices [GalaFLEX]

00855920006607GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006591GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006690GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006683GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006676GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006669GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006652GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006645GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006638GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006621GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006614GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006584GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006577GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
00855920006560GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate

Trademark Results [GalaFLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALAFLEX
GALAFLEX
85273670 4301942 Live/Registered
GALATEA SURGICAL, INC.
2011-03-22
GALAFLEX
GALAFLEX
85197843 not registered Dead/Abandoned
GENOMMA LAB INTERNACIONAL, S.A.B. DE C.V.
2010-12-14
GALAFLEX
GALAFLEX
72143407 0748771 Dead/Expired
KIEFER K. G.
1962-04-30

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