FLEX-BAND OVAL 1 1/4 X 1 2400/CS - FLEX-BAND OVAL 1 1/4 X 1 2400/CS - PAUL HARTMANN AG

Duns Number:315768788

Device Description: FLEX-BAND OVAL 1 1/4 X 1 2400/CS

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More Product Details

Catalog Number

-

Brand Name

FLEX-BAND OVAL 1 1/4 X 1 2400/CS

Version/Model Number

46150000

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

fd36b32e-2caf-4527-8c77-f04a48d80695

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

40612553015288

Quantity per Package

24

Contains DI Package

20612553015284

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