Catalog Number

AACO28111920

Brand Name

FemiLift Slim Sleeve 24

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

391e8f95-b911-436f-8c0f-c529fe64a08a

Public Version Date

December 31, 2020

Public Version Number

1

DI Record Publish Date

December 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-