Catalog Number

91001

Brand Name

Microlyte AG

Version/Model Number

91001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153756,K153756,K153756

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

b427d3e3-153c-44b4-b4f7-9025833265ce

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

February 01, 2017

Package DI Number

B519910012

Quantity per Package

10

Contains DI Package

B519910011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton