MicroDoc Mini Stingray and Drape Set - MicroDoc Mini Stingray and Drape Set, Each - Pensar Medical, LLC

Duns Number:079262228

Device Description: MicroDoc Mini Stingray and Drape Set, Each

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More Product Details

Catalog Number

-

Brand Name

MicroDoc Mini Stingray and Drape Set

Version/Model Number

8463550 2003

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

K200223

Product Code Details

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Device Record Status

Public Device Record Key

15eb21a9-11d1-4276-bde1-9f00770ea8f6

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