WoundPro Hydrophobic Foam Dressing, Large - WoundPro Hydrophobic Foam Dressing, Large, Case - Pensar Medical, LLC

Duns Number:079262228

Device Description: WoundPro Hydrophobic Foam Dressing, Large, Case of 10

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More Product Details

Catalog Number

-

Brand Name

WoundPro Hydrophobic Foam Dressing, Large

Version/Model Number

8463540 0579

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"

-

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

K150960,K150960

Product Code Details

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Device Record Status

Public Device Record Key

4545daf3-2464-4364-9f42-fca7da0dba37

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PENSAR MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 45