Catalog Number

-

Brand Name

PERL Localization Device, 16Ga x 11.5cm Needle

Version/Model Number

R15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

GDF

Product Code Name

Guide, Needle, Surgical

Public Device Record Key

b0e22803-56fc-4a1c-b61d-64ceb39c629b

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 08, 2018

Package DI Number

20851766006188

Quantity per Package

1

Contains DI Package

00851766006184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Carton, 1up