Tepha, Incorporated

Matched from indexed company URL: Tepha, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005670760	3005670760	Tepha, Incorporated	1	N	2026-01-01	99 Hayden Avenue, Suite 360 Lexington MA US 02421

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00810054980797	GalaFLEX LITE - GalaFLEX LITE Scaffold, 22.0 cm, Circle	7813571750	contact@galateasurgical.com
00810054980797	GalaFLEX LITE - GalaFLEX LITE Scaffold, 22.0 cm, Circle	781-357-1750	contact@galateasurgical.com

galateasurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
71859	2061214409	K233999	GalaFLEX LITE Scaffold	OOD	2024-04-09
71859	1777629988	K162922	GalaFORM 3D	OOD	2017-02-23
71859	1424615133	K161092	GalaSHAPE 3D	OOD	2016-08-23
71859	1658610574	K140533	GALAFLEX MESH	OOD	2014-05-21
71859	1053093756	K132348	TEPHAFLEX BRAIDED SUTURE	NWJ	2013-09-05
71859	1314046500	K130326	TEPHAFLEX MELTBLOWN CONSTRUCT	OOD	2013-05-07
71859	1604516239	K113723	TEPHAFLEX MESH	OOD	2012-02-15
71859	1362761894	K113721	TEPHAFLEX LIGHT MESH	OOD	2012-02-15
71859	1200949832	K111946	TEPHAFLEX MESH	OOD	2011-09-26
71859	1447529314	K101287	TEPHAFLEX COMPOSITE MESH	OWT	2010-08-30
71859	1081952832	K091633	TEPHAFLEX SURGICAL FILM	OOD	2009-08-07
71859	1628523822	K082178	TEPHAFLEX ABSORBABLE SUTURE	NWJ	2008-10-30
71859	1009083044	K081099	TEPHAFLEX ABSORBABLE SUTURE	NWJ	2008-07-15
71859	1358698513	K072520	TEPHAFLEX SURGICAL FILM	FTL	2007-11-29
71859	1137263360	K070894	TEPHAFLEX SURGICAL MESH	OOD	2007-04-13
71859	1354389918	DEN060003	TEPHAFLEX ABSORBABLE SUTURE	NWJ	2007-02-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OOD	13	2024-04-09
NWJ	4	2013-09-05
OWT	1	2010-08-30
FTL	1	2007-11-29

PMN#

GalaFLEX LITE Scaffold

2024-04-09

Tepha, Inc.

SurgiLattice Scaffold

2021-08-19

Tepha, Inc.

GalaSTITCH Absorbable Monofilament Suture

2021-05-27

Tepha, Inc.

GalaFORM 3D

2017-02-23

TEPHA, INC.

GalaSHAPE 3D

2016-08-23

Tepha, Inc.

GALAFLEX MESH

2014-05-21

TEPHA, INC.

TEPHAFLEX BRAIDED SUTURE

2013-09-05

TEPHA, INC.

TEPHAFLEX MELTBLOWN CONSTRUCT

2013-05-07

TEPHA, INC.

TEPHAFLEX LIGHT MESH

2012-02-15

TEPHA, INC.

TEPHAFLEX MESH

2012-02-15

TEPHA, INC.

TEPHAFLEX MESH

2011-09-26

TEPHA, INC.

TEPHAFLEX COMPOSITE MESH

2010-08-30

TEPHA, INC.

TEPHAFLEX SURGICAL FILM

2009-08-07

TEPHA, INC.

TEPHAFLEX ABSORBABLE SUTURE

2008-10-30

TEPHA, INC.

TEPHAFLEX ABSORBABLE SUTURE

2008-07-15

TEPHA, INC.

TEPHAFLEX SURGICAL FILM

2007-11-29

TEPHA, INC.

TEPHAFLEX SURGICAL MESH

2007-04-13

TEPHA, INC.

GUDID#

GalaFLEX Scaffold - GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle

Tepha, Inc.

2016-05-27

GalaFLEX Scaffold - GalaFLEX Scaffold, 5.0 cm x 15.0 cm, Rectangle

Tepha, Inc.

2016-05-27

GalaFLEX Scaffold - GalaFLEX Scaffold, 5.0 cm x 20.0 cm, Rectangle

Tepha, Inc.

2016-05-27

GalaFLEX Scaffold - GalaFLEX Scaffold, 10.0 cm x 20.0 cm, Rectangle

Tepha, Inc.

2016-05-27

GalaFLEX Scaffold - GalaFLEX Scaffold, 15.0 cm x 20.0 cm, Rectangle

Tepha, Inc.

2016-05-27

GalaFLEX LITE - GalaFLEX LITE Scaffold, 22.0 cm, Circle

Tepha, Inc.

2023-07-26

GalaFLEX LITE - GalaFLEX LITE Scaffold, 25.0 cm, Circle

Tepha, Inc.

2023-07-26

GalaFLEX LITE - GalaFLEX LITE Scaffold, 20.0 cm x 25.0 cm, Rectangle

Tepha, Inc.

2023-07-26

GalaFLEX LITE - GalaFLEX LITE Scaffold, 25.0 cm x 30.0 cm, Rectangle

Tepha, Inc.

2023-07-26

GalaFLEX LITE - GalaFLEX LITE Scaffold, 2.5 cm x 7.6 cm, Rectangle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 5.0 cm x 15.0 cm, Rectangle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 5.0 cm x 20.0 cm, Rectangle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 10.0 cm x 20.0 cm, Rectangle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 15.0 cm x 20.0 cm, Rectangle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE 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.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 13.0 cm, Circle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 15.0 cm, Circle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 17.0 cm, Circle

Tepha, Inc.

2021-07-20

GalaFLEX LITE - GalaFLEX LITE Scaffold, 19.0 cm, Circle

Tepha, Inc.

2021-07-20

GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 1)

Tepha, Inc.

2020-09-29

GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 2)

Tepha, Inc.

2020-09-29

GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 1)

Tepha, Inc.

2020-09-29

GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 2)

Tepha, Inc.

2020-09-29

GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 1)

Tepha, Inc.

2020-09-29

GalaFLEX 3DR - GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 2)

Tepha, Inc.

2020-09-29

GalaFLEX 3DR - 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.

2020-09-29

GalaFLEX 3DR - 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.

2020-09-29

GalaFLEX 3DR - 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.

2020-09-29

GalaFLEX 3DR - 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.

2020-09-29

GalaFLEX 3DR - 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.

2020-09-29

GalaFLEX 3DR - 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.

2020-09-29

GalaFLEX 3DR - 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.

2020-09-29

GalaFLEX 3D - GalaFLEX 3D Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 1)

Tepha, Inc.

2020-09-29

GalaFLEX 3D - GalaFLEX 3D Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 2)

Tepha, Inc.

2020-09-29

GalaFLEX 3D - GalaFLEX 3D Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 1

Tepha, Inc.

2020-09-29

GalaFLEX 3D - GalaFLEX 3D Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 2)

Tepha, Inc.

2020-09-29

GalaFLEX 3D - GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 1)

Tepha, Inc.

2020-09-29

GalaFLEX 3D - GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 2)

Tepha, Inc.

2020-09-29

GalaFLEX 3D - GalaFLEX 3D Scaffold, 7.6 cm x 20.3 cm, Rectangle (Contents: 1)

Tepha, Inc.

2020-09-29

GalaFLEX 3D - 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.

2020-09-29

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