Catalog Number

-

Brand Name

23GA Straight Pick

Version/Model Number

PD123.03AD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K980797,K980797

Product Code

MPA

Product Code Name

Endoilluminator

Public Device Record Key

457e8ba1-dd4b-4abe-ac85-32048684a3f0

Public Version Date

November 12, 2020

Public Version Number

1

DI Record Publish Date

November 04, 2020

Package DI Number

10632307002264

Quantity per Package

5

Contains DI Package

00632307002267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box