PMI - PMI Disposable Operative Cholangiogram Catheter - PROGRESSIVE MEDICAL, INC.

Duns Number:192135242

Device Description: PMI Disposable Operative Cholangiogram Catheter 20" for percutaneous insertion

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More Product Details

Catalog Number

PMICATH20

Brand Name

PMI

Version/Model Number

PMICATH20

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

GBZ

Product Code Name

Catheter, Cholangiography

Device Record Status

Public Device Record Key

8138af6f-939e-4e8d-85ba-33c8c3faacf1

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

January 22, 2018

Additional Identifiers

Package DI Number

00812608021741

Quantity per Package

10

Contains DI Package

00812608021734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"PROGRESSIVE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 112