Catalog Number

-

Brand Name

R.T.R Membrane

Version/Model Number

9626N

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

-

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

f7b8256c-48d9-4922-b156-d5335b26c4d2

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

July 14, 2017

Package DI Number

13760140703615

Quantity per Package

12

Contains DI Package

03760140703618

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-