Catalog Number

-

Brand Name

Sklar®

Version/Model Number

91-5082

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"

Yes

For Single-Use

-

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

HDL

Product Code Name

RETRACTOR, VAGINAL

Public Device Record Key

b402f9cd-8a0d-48d6-a3b1-68995d95c58d

Public Version Date

April 30, 2018

Public Version Number

1

DI Record Publish Date

March 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-