Catalog Number

-

Brand Name

SurgyNeedle

Version/Model Number

780-415

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

86586307-090f-4571-a5ed-f2a7e5ead999

Public Version Date

May 18, 2020

Public Version Number

1

DI Record Publish Date

May 10, 2020

Package DI Number

00810014630120

Quantity per Package

10

Contains DI Package

00810014630113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box