AMSure® PVC Intermittent Catheter - AMSure® PVC Intermittent Catheterwith RPOLISHED® - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: AMSure® PVC Intermittent Catheterwith RPOLISHED® Eyes, Male 16" Length

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More Product Details

Catalog Number

AS961616

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

b19efd6a-6ecf-4e22-babd-3f8677cc17c9

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

40704411004005

Quantity per Package

50

Contains DI Package

10704411004004

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