Catalog Number

22-1501

Brand Name

N/A

Version/Model Number

22-1501

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

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

1c411a57-3802-412c-9651-995d0d0bdf12

Public Version Date

January 31, 2020

Public Version Number

4

DI Record Publish Date

August 30, 2015

Package DI Number

20817470002724

Quantity per Package

10

Contains DI Package

00817470002720

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX