Catalog Number

227-7116

Brand Name

SCOTT'S MYLAR MATRIX STRIPS .002 1000/pkg

Version/Model Number

227-7116

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JEP

Product Code Name

RETAINER, MATRIX

Public Device Record Key

e213087f-d3e6-4d90-8284-5c8b5486657e

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-