Sorbalgon Ag st 15x15cm P5 - Sorbalgon Ag st 15x15cm P5 - PAUL HARTMANN AG

Duns Number:315768788

Device Description: Sorbalgon Ag st 15x15cm P5

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More Product Details

Catalog Number

-

Brand Name

Sorbalgon Ag st 15x15cm P5

Version/Model Number

999610

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)

Yes

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

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

ec5b67c5-e568-489b-b5e8-218bc290a27a

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

20612553018087

Quantity per Package

5

Contains DI Package

10612553018080

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