SimPro™ Core - Single Use Urinary Catheter with water sachet. - Dentsply Ih AB

Duns Number:354059073

Device Description: Single Use Urinary Catheter with water sachet. Tiemann 16" 10FR

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More Product Details

Catalog Number

5451000

Brand Name

SimPro™ Core

Version/Model Number

5451000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 14, 2022

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)

-

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

21ed0e14-122f-4b48-bfc8-d7d40d7f71cc

Public Version Date

May 09, 2022

Public Version Number

2

DI Record Publish Date

February 26, 2019

Additional Identifiers

Package DI Number

07392532194764

Quantity per Package

4

Contains DI Package

07392532194757

Package Discontinue Date

April 13, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"DENTSPLY IH AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 71