GalaSHAPE 3D CESH05

GUDID 00855920006461

GalaSHAPE 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 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 ID00855920006461
NIH Device Record Keyd0888378-05cf-463f-a58d-14471dbe2933
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaSHAPE 3D
Version Model Number100042-25
Catalog NumberCESH05
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

Device Dimensions

Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter
Width21 Centimeter
Height7.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100855920006461 [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 Date2020-02-12
Device Publish Date2020-02-04

On-Brand Devices [GalaSHAPE 3D]

00855920006416GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006409GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006393GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006386GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006379GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006362GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006218GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006201GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006195GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006188GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006171GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006164GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006157GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006140GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate
00855920006461GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006447GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006423GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006553GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006546GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006539GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006522GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006515GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006508GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006492GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006485GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006478GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006454GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty
00855920006430GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty

Trademark Results [GalaSHAPE 3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALASHAPE 3D
GALASHAPE 3D
86953182 not registered Dead/Abandoned
Galatea Surgical, Inc.
2016-03-25

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