NUVO PADS - Split leg Pad, R - Medical Illumination International Inc.

Duns Number:093357739

Device Description: Split leg Pad, R

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More Product Details

Catalog Number

-

Brand Name

NUVO PADS

Version/Model Number

B2DCP001635

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)

-

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

FWZ

Product Code Name

Operating Room Accessories Table Tray

Device Record Status

Public Device Record Key

eac4c136-bf64-46a0-931e-77b25ea2a768

Public Version Date

September 19, 2022

Public Version Number

2

DI Record Publish Date

March 31, 2020

Additional Identifiers

Package DI Number

01816835023409

Quantity per Package

1

Contains DI Package

00816835023400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"MEDICAL ILLUMINATION INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 112
2 A medical device with a moderate to high risk that requires special controls. 58