Super View® Pack, Pivot Plus (40101+40227) - 1 Each SUPER VIEW® Pack, Pivot Plus & 1 Each - OCULUS SURGICAL INC

Duns Number:015409582

Device Description: 1 Each SUPER VIEW® Pack, Pivot Plus & 1 Each 40101 Microscope Head Cover Drape

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More Product Details

Catalog Number

40229

Brand Name

Super View® Pack, Pivot Plus (40101+40227)

Version/Model Number

40229

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"

Yes

For Single-Use

Yes

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

LRO

Product Code Name

General Surgery Tray

Device Record Status

Public Device Record Key

0946f9c8-d5ab-4d94-96ca-083745cac348

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

November 24, 2020

Additional Identifiers

Package DI Number

00852475007097

Quantity per Package

8

Contains DI Package

00852475007080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"OCULUS SURGICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 8