NOVO Health Services, LLC - REX ONSITE LP DECON GWN XLG NS - NOVO HEALTH SERVICES, LLC

Duns Number:069936106

Device Description: REX ONSITE LP DECON GWN XLG NS

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More Product Details

Catalog Number

123878

Brand Name

NOVO Health Services, LLC

Version/Model Number

123878

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

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

FYC

Product Code Name

Gown, Isolation, Surgical

Device Record Status

Public Device Record Key

8a3990de-0319-43f4-ab7b-8c66aee9b34e

Public Version Date

July 31, 2020

Public Version Number

2

DI Record Publish Date

October 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVO HEALTH SERVICES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 226
2 A medical device with a moderate to high risk that requires special controls. 859