GalaFLEX 3DR - GalaFLEX 3DR scaffold is a single layer - Tepha, Inc.

Duns Number:039856765

Device Description: GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydro 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.

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More Product Details

Catalog Number

FR3D11

Brand Name

GalaFLEX 3DR

Version/Model Number

100043-11

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162922

Product Code Details

Product Code

OOD

Product Code Name

Surgical Film

Device Record Status

Public Device Record Key

b758afa7-edb5-4124-bf8c-ec6ff35d8e5b

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEPHA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 146