Sklar® - SKLAR CORPORATION

Duns Number:006966006

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More Product Details

Catalog Number

-

Brand Name

Sklar®

Version/Model Number

90-5291

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

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 Details

Product Code

HHW

Product Code Name

PESSARY, VAGINAL

Device Record Status

Public Device Record Key

9bc33874-3ffa-4694-95c6-a94dd1389123

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

October 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKLAR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13420
2 A medical device with a moderate to high risk that requires special controls. 881