Catalog Number

500-LB/A

Brand Name

DualCap®

Version/Model Number

10884450309367

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

-

Product Code

LKB

Product Code Name

Pad, alcohol, device disinfectant

Public Device Record Key

21fe81cf-0658-4e15-84e7-b90bb21e981c

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 28, 2018

Package DI Number

20884450309364

Quantity per Package

12

Contains DI Package

10884450309367

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-