Catalog Number

880854

Brand Name

Sasmar Classic

Version/Model Number

118ml

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

K131084,K131084,K131084

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

d30030e9-bc0d-49eb-802f-d6e44d66a70e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

29337213008543

Quantity per Package

8

Contains DI Package

19337213008546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton