Catalog Number

234-020-280

Brand Name

NA

Version/Model Number

234-020-280

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDD

Product Code Name

KIT, SURGICAL INSTRUMENT, DISPOSABLE

Public Device Record Key

ccf948a8-da29-4d97-8609-2b96635bb8f9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2015

Package DI Number

37613154643265

Quantity per Package

6

Contains DI Package

07613154643264

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack