AccessGUDID - DEVICE: GalaFLEX 3D (00810054980384)

GUDID

Device Identifier (DI) Information

Brand Name: GalaFLEX 3D
Version or Model: 100042-13
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SH3D13
Company Name: Tepha, Inc.

Primary DI Number: 00810054980384
Issuing Agency: GS1
Commercial Distribution End Date: July 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 039856765 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44688	Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable	An 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OOD	Surgical Film

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161092	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 7.6 Centimeter

Device Record Status

Public Device Record Key: 557caddf-87fb-4362-94c0-1c0c86a26544
Public Version Date: September 17, 2025
Public Version Number: 6
DI Record Publish Date: September 29, 2020