REB LF ST 4X10 10/CS - REB LF ST 4X10 10/CS - PAUL HARTMANN AG

Duns Number:315768788

Device Description: REB LF ST 4X10 10/CS

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More Product Details

Catalog Number

-

Brand Name

REB LF ST 4X10 10/CS

Version/Model Number

35410000

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

7f60c0f3-afa7-43b9-aba9-65545183bd83

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

40612553011662

Quantity per Package

10

Contains DI Package

10612553011661

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