Catalog Number

281020545

Brand Name

Surgilube

Version/Model Number

281020545

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

-

Product Code

KMJ

Product Code Name

Lubricant, patient

Public Device Record Key

4d7d1f1f-84a4-49a8-b537-58aaeac557fa

Public Version Date

September 27, 2018

Public Version Number

1

DI Record Publish Date

August 27, 2018

Package DI Number

20851809002412

Quantity per Package

6

Contains DI Package

10851809002415

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case