Catalog Number

GCT2420

Brand Name

GENOSS Collagen Membrane

Version/Model Number

GCT2420

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K102307

Product Code

NPL

Product Code Name

Barrier, animal source, intraoral

Public Device Record Key

103efe0b-d5dc-4532-b496-005493043a62

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-