Sklar® - DE EXPLORER #5 - SKLAR CORPORATION

Duns Number:006966006

Device Description: DE EXPLORER #5

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More Product Details

Catalog Number

-

Brand Name

Sklar®

Version/Model Number

48-472

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

EKB

Product Code Name

EXPLORER, OPERATIVE

Device Record Status

Public Device Record Key

dcbcd541-d89b-4d91-9c16-2663a478cff4

Public Version Date

January 03, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2018

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