LoFric® Elle™ - Single Use Urinary Catheter LoFric Elle Nelaton - Dentsply Ih AB

Duns Number:354059073

Device Description: Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR

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More Product Details

Catalog Number

4181250

Brand Name

LoFric® Elle™

Version/Model Number

4181250

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)

-

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

9cde32e4-4e54-4403-9ff8-dc568ab247c3

Public Version Date

April 11, 2022

Public Version Number

1

DI Record Publish Date

April 01, 2022

Additional Identifiers

Package DI Number

07392532274336

Quantity per Package

2

Contains DI Package

07392532274329

Package Discontinue Date

-

Package Status

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