Modified Potts/Cournand Needle - Modified Potts/Cournand Needle 18ga x 5.7cm - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Modified Potts/Cournand Needle 18ga x 5.7cm

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More Product Details

Catalog Number

MPCN1802

Brand Name

Modified Potts/Cournand Needle

Version/Model Number

MPCN1802

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

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

K974745,K974745

Product Code Details

Product Code

DRC

Product Code Name

Trocar

Device Record Status

Public Device Record Key

e2a5f2e3-4261-45d8-8621-ae039f786c15

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

20886333002881

Quantity per Package

25

Contains DI Package

00886333002887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205