FLEXICON ST 6X4.1 48/CS - FLEXICON ST 6X4.1 48/CS - PAUL HARTMANN AG

Duns Number:315768788

Device Description: FLEXICON ST 6X4.1 48/CS

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More Product Details

Catalog Number

-

Brand Name

FLEXICON ST 6X4.1 48/CS

Version/Model Number

19600000

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

FQM

Product Code Name

Bandage, Elastic

Device Record Status

Public Device Record Key

94f412a8-a525-4319-8d90-bf415b426523

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

20612553013235

Quantity per Package

48

Contains DI Package

10612553013238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PAUL HARTMANN AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 99
U Unclassified 1