C2 CryoBalloon Nitroclip - NitroClip - PENTAX OF AMERICA, INC.

Duns Number:083211284

Device Description: NitroClip

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More Product Details

Catalog Number

-

Brand Name

C2 CryoBalloon Nitroclip

Version/Model Number

FG-1050

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

K190194

Product Code Details

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

d8cd5847-b2b0-4e3c-a651-b6866783a3cd

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

August 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PENTAX OF AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 247
2 A medical device with a moderate to high risk that requires special controls. 425