Catalog Number

AACO28111922

Brand Name

FemiLift Sleeve

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K103501

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

98f3362e-0cc7-44af-b418-e418e9a3d3ad

Public Version Date

December 11, 2020

Public Version Number

1

DI Record Publish Date

December 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-