GP General Purpose Drainage Catheter - HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER - URESIL, LLC

Duns Number:192559557

Device Description: HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 12F

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More Product Details

Catalog Number

MPL2T-1430H

Brand Name

GP General Purpose Drainage Catheter

Version/Model Number

MPL2T-1430H

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

GBO

Product Code Name

Catheter, Nephrostomy, General & Plastic Surgery

Device Record Status

Public Device Record Key

ca121dd2-05c0-4c75-9ab3-3add20fd60af

Public Version Date

May 05, 2022

Public Version Number

1

DI Record Publish Date

April 27, 2022

Additional Identifiers

Package DI Number

10817640021657

Quantity per Package

5

Contains DI Package

00817640021650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser

"URESIL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 179
2 A medical device with a moderate to high risk that requires special controls. 77
U Unclassified 24