FDA.reportPublic FDA data

GalaFLEX LITE

Primary DI
00810054980810
Brand
GalaFLEX LITE
Company
Tepha, Inc.
Model
100027-03
Catalog number
GFLT2025
Device description
GalaFLEX LITE Scaffold, 20.0 cm x 25.0 cm, Rectangle
Published
2023-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OODSurgical Film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OODSurgical FilmGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113721000TEPHAFLEX LIGHT MESHTepha, Inc.2012-02-15OOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810054980810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810054980810008100549808108100549808100810054980810

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Centimeter
Width20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7813571750contact@galateasurgical.com
781-357-1750contact@galateasurgical.com

Regulatory Flags#

DUNS number
039856765
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855920006003GalaFLEX Scaffold100035-05GP01032016-05-27
00855920006010GalaFLEX Scaffold100035-01GP02062016-05-27
00855920006027GalaFLEX Scaffold100035-14GP02082016-05-27
00855920006034GalaFLEX Scaffold100035-15GP04082016-05-27
00855920006041GalaFLEX Scaffold100035-09GP06082016-05-27
00810054980797GalaFLEX LITE100027-33GFLT00222023-07-26
00810054980803GalaFLEX LITE100027-34GFLT00252023-07-26
00810054980827GalaFLEX LITE100027-10GFLT25302023-07-26
00810054980544GalaFLEX LITE100027-05GFLT02072021-07-20
00810054980551GalaFLEX LITE100027-01GFLT05152021-07-20
00810054980568GalaFLEX LITE100027-14GFLT05202021-07-20
00810054980575GalaFLEX LITE100027-15GFLT10202021-07-20
00810054980582GalaFLEX LITE100027-09GFLT15202021-07-20
00810054980599GalaFLEX LITE100027-06GFLT00082021-07-20
00810054980605GalaFLEX LITE100027-29GFLT00132021-07-20
00810054980612GalaFLEX LITE100027-30GFLT00152021-07-20
00810054980629GalaFLEX LITE100027-31GFLT00172021-07-20
00810054980636GalaFLEX LITE100027-32GFLT00192021-07-20
00810054980001GalaFLEX 3DR100043-01FR3D012020-09-29
00810054980018GalaFLEX 3DR100043-02FR3D022020-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801741233279GalaFLEX 3DRDavol Inc.OOD2026-04-30
10801741233521GalaFLEX 3DDavol Inc.OOD2026-04-30
10801741234368GalaFLEX 3DDavol Inc.OOD2026-04-30
10801741234382GalaFLEX 3DDavol Inc.OOD2026-04-30
10801741234412GalaFLEX 3DRDavol Inc.OOD2026-04-30
10801741234436GalaFLEX 3DRDavol Inc.OOD2026-04-30
00801741233265GalaFLEX 3DRDavol Inc.OOD2026-04-30
00801741233494GalaFLEX 3DDavol Inc.OOD2026-04-30
00801741234354GalaFLEX 3DDavol Inc.OOD2026-04-30
00801741234378GalaFLEX 3DDavol Inc.OOD2026-04-30
00801741234392GalaFLEX 3DDavol Inc.OOD2026-04-30
00801741234408GalaFLEX 3DRDavol Inc.OOD2026-04-30
00801741234422GalaFLEX 3DRDavol Inc.OOD2026-04-30
00801741233678GalaFLEXDavol Inc.OOD2025-09-25
00801741233685GalaFLEXDavol Inc.OOD2025-09-25
00801741233692GalaFLEXDavol Inc.OOD2025-09-25
00801741233708GalaFLEXDavol Inc.OOD2025-09-25
00801741233715GalaFLEXDavol Inc.OOD2025-09-25
00801741233722GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233739GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233746GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233753GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233760GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233777GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233784GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233791GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233814GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233821GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233838GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233852GalaFLEX LITEDavol Inc.OOD2025-09-25