Catalog Number

-

Brand Name

Timm Medical

Version/Model Number

57-05-144738

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

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

K864556,K864556

Product Code

KMJ

Product Code Name

Lubricant, Patient

Public Device Record Key

261b2b62-4073-41e1-8541-7baa1e816de9

Public Version Date

November 19, 2019

Public Version Number

1

DI Record Publish Date

November 11, 2019

Package DI Number

10855683006736

Quantity per Package

100

Contains DI Package

00855683006739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case