AccessGUDID - DEVICE: GalaFLEX 3DR (00810054980063)

GUDID

Device Identifier (DI) Information

Brand Name: GalaFLEX 3DR
Version or Model: 100043-07
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FR3D07
Company Name: Tepha, Inc.

Primary DI Number: 00810054980063
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 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.

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), 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OOD	Surgical Film

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162922	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
Height: 7.6 Centimeter
Length: 20.3 Centimeter

Device Record Status

Public Device Record Key: 0d62be1b-ebf1-4b8f-a679-9317a7639ecc
Public Version Date: July 12, 2024
Public Version Number: 4
DI Record Publish Date: September 29, 2020