FDA.reportPublic FDA data

GalaFLEX 3D

Primary DI
00810054980322
Brand
GalaFLEX 3D
Company
Tepha, Inc.
Model
100042-07
Catalog number
SH3D07
Device description
GalaFLEX 3D Scaffold, 7.6 cm x 20.3 cm, Rectangle (Contents: 1)
Published
2020-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810054980322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810054980322008100549803228100549803220810054980322

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), polyglycolide] 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
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
039856765
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00810054980810GalaFLEX LITE100027-03GFLT20252023-07-26

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