Precept® - Safe-T-Tread Shoe Cover - Non-Conductive - PRECEPT MEDICAL PRODUCTS, INC.

Duns Number:783912892

Device Description: Safe-T-Tread Shoe Cover - Non-Conductive

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More Product Details

Catalog Number

-

Brand Name

Precept®

Version/Model Number

42135

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FXP

Product Code Name

Cover, Shoe, Operating-Room

Device Record Status

Public Device Record Key

f3326f23-9cfd-4967-85ae-8a9d39d75565

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRECEPT MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2