NOVO Health Services, LLC - 5 LP DECON GWN, SM N/S - NOVO HEALTH SERVICES, LLC

Duns Number:069936106

Device Description: 5 LP DECON GWN, SM N/S

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More Product Details

Catalog Number

8515

Brand Name

NOVO Health Services, LLC

Version/Model Number

8515

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"

-

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

c0f52427-f042-4220-85bf-71669bcb8f52

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