Catalog Number

UBER-FOIL

Brand Name

überlube

Version/Model Number

UBER-FOIL

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151647,K151647

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

71b30058-4e52-489d-9623-2dc3ae7b19f4

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

October 03, 2016

Package DI Number

10851674003081

Quantity per Package

100

Contains DI Package

00851674003084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case