Veress Needle - UNIMAX MEDICAL SYSTEMS INC.

Duns Number:658122465

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More Product Details

Catalog Number

-

Brand Name

Veress Needle

Version/Model Number

FVN115000

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

K111441,K111441,K111441

Product Code Details

Product Code

FHO

Product Code Name

Pneumoperitoneum Needle

Device Record Status

Public Device Record Key

0231f24d-ce51-44bb-80b8-6ad0740640b9

Public Version Date

July 14, 2020

Public Version Number

4

DI Record Publish Date

June 19, 2017

Additional Identifiers

Package DI Number

24714127862020

Quantity per Package

100

Contains DI Package

14714127862023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"UNIMAX MEDICAL SYSTEMS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 67