PROWLER SELECT - PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE - Medos International Sàrl

Duns Number:482661753

Device Description: PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE STRAIGHT Infusion Catheter 2.8F (0.95mm) 2.3F ( PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE STRAIGHT Infusion Catheter 2.8F (0.95mm) 2.3F (0.75mm) .021 Inch (0.5mm) 15cm 170cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1mm)

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More Product Details

Catalog Number

606S272X

Brand Name

PROWLER SELECT

Version/Model Number

606-S272X

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

K021591

Product Code Details

Product Code

KRA

Product Code Name

Catheter, continuous flush

Device Record Status

Public Device Record Key

e3266150-760b-4533-ac15-cd01f748f4a0

Public Version Date

January 29, 2020

Public Version Number

5

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDOS INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 972
2 A medical device with a moderate to high risk that requires special controls. 6382
3 A medical device with high risk that requires premarket approval 20
U Unclassified 20