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

Duns Number:192559557

Device Description: HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER, 8F

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More Product Details

Catalog Number

MPL2-0830HB

Brand Name

GP General Purpose Drainage Catheter

Version/Model Number

MPL2-0830HB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

February 28, 2027

Issuing Agency

In HIBCC

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

c3a37abe-2d4c-40ea-a66d-57c349a57cb5

Public Version Date

April 29, 2022

Public Version Number

5

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

H862MPL20830HB2

Quantity per Package

6

Contains DI Package

H862MPL20830HB1

Package Discontinue Date

February 28, 2027

Package Status

In Commercial Distribution

Package Type

Shipper

"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