NOVO Health Services, LLC - SPLIT DRAPE (3 X 26) - NOVO HEALTH SERVICES, LLC

Duns Number:069936106

Device Description: SPLIT DRAPE (3 X 26)

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More Product Details

Catalog Number

1880B

Brand Name

NOVO Health Services, LLC

Version/Model Number

1880

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 02, 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

K080796

Product Code Details

Product Code

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

0ff8ee83-d815-417e-93a7-0b4905b7e935

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

October 09, 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