FDA.reportPublic FDA data

GalaFLEX 3DR

Primary DI
00810054980223
Brand
GalaFLEX 3DR
Company
Tepha, Inc.
Model
100043-31
Catalog number
CEFR11
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
New
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

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
00810054980223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810054980223008100549802238100549802230810054980223

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
Height2.5Centimeter
Width10.2Centimeter

Sterilization Methods#

Method table
Method

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
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
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

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