NOVO Health Services, LLC - 5/PK L4 PREM DECON GOWN LG NS - NOVO HEALTH SERVICES, LLC

Duns Number:069936106

Device Description: 5/PK L4 PREM DECON GOWN LG NS

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More Product Details

Catalog Number

699200

Brand Name

NOVO Health Services, LLC

Version/Model Number

699200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 09, 2018

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

K920404

Product Code Details

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Device Record Status

Public Device Record Key

d38e79e6-67fa-4596-a2fb-6fd49262e7ad

Public Version Date

November 01, 2018

Public Version Number

1

DI Record Publish Date

October 01, 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