AMSure® PVC Intermittent Catheter - AMSure® PVC Intermittent CatheterMale 16" Length - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: AMSure® PVC Intermittent CatheterMale 16" Length Coude Tip

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More Product Details

Catalog Number

AS861618C

Brand Name

AMSure® PVC Intermittent Catheter

Version/Model Number

1

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

EZD

Product Code Name

Catheter, Straight

Device Record Status

Public Device Record Key

2ec5196f-8df9-4262-8e29-7dc845f52500

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

November 10, 2017

Additional Identifiers

Package DI Number

40704411007235

Quantity per Package

20

Contains DI Package

30704411007238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"AMSINO INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 89
2 A medical device with a moderate to high risk that requires special controls. 411
U Unclassified 1