FDA.reportPublic FDA data

GalaFLEX 3DR

Primary DI
00810054980063
Brand
GalaFLEX 3DR
Company
Tepha, Inc.
Model
100043-07
Catalog number
FR3D07
Device description
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.
Published
2020-09-29
Public version status
Update
Distribution status
Not 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
K162922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162922000GalaFORM 3DTepha, Inc.2017-02-23OOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810054980063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810054980063008100549800638100549800630810054980063

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, synthetic polymer, bioabsorbableA sterile, flat, or three-dimensional (3-D), woven/knitted or porous implantable device made of a bioabsorbable synthetic polymer [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height7.6Centimeter
Length20.3Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
00810054980001GalaFLEX 3DR100043-01FR3D012020-09-29
00810054980018GalaFLEX 3DR100043-02FR3D022020-09-29
00810054980025GalaFLEX 3DR100043-03FR3D032020-09-29
00810054980032GalaFLEX 3DR100043-04FR3D042020-09-29
00810054980049GalaFLEX 3DR100043-05FR3D052020-09-29
00810054980056GalaFLEX 3DR100043-06FR3D062020-09-29
00810054980261GalaFLEX 3D100042-01SH3D012020-09-29
00810054980278GalaFLEX 3D100042-02SH3D022020-09-29
00810054980285GalaFLEX 3D100042-03SH3D032020-09-29
00810054980292GalaFLEX 3D100042-04SH3D042020-09-29
00810054980308GalaFLEX 3D100042-05SH3D052020-09-29
00810054980315GalaFLEX 3D100042-06SH3D062020-09-29
00810054980322GalaFLEX 3D100042-07SH3D072020-09-29
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

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