Catalog Number

-

Brand Name

StripRight

Version/Model Number

11384

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HRT

Product Code Name

STRIPPER, SURGICAL

Public Device Record Key

2b922061-399e-434a-8373-1c456aec8e23

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 03, 2016

Package DI Number

B145114831

Quantity per Package

5

Contains DI Package

B145113840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box