GalaFORM 3D CEFR04

GUDID 00855920006737

GalaFORM 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 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 ID00855920006737
NIH Device Record Keyfe833225-973c-4de5-9b00-5ee067ce4e91
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaFORM 3D
Version Model Number100043-24
Catalog NumberCEFR04
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
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com
Phone781-357-1750
Emailcontact@galateasurgical.com

Device Dimensions

Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter
Width18.5 Centimeter
Height6.4 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100855920006737 [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 [GalaFORM 3D]

00855920006355GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006348GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006331GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006324GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006317GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006300GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006287GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006270GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006263GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006256GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006249GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006232GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006225GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
00855920006829GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006812GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006805GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006799GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006782GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006775GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006768GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006751GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006744GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006737GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006720GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006713GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
00855920006706GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr

Trademark Results [GalaFORM 3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALAFORM 3D
GALAFORM 3D
86663865 not registered Dead/Abandoned
GALATEA SURGICAL, INC.
2015-06-16

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