Sklar - HUSTINX PERINEAL SPREADER8.75 IN - SKLAR CORPORATION

Duns Number:006966006

Device Description: HUSTINX PERINEAL SPREADER8.75 IN

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More Product Details

Catalog Number

-

Brand Name

Sklar

Version/Model Number

60-7430

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

-

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

5b4848a2-3866-4bcb-9169-da3dc343136b

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

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