Catalog Number

048-1000

Brand Name

OcciGuide

Version/Model Number

ER GUIDE 1010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 25, 2021

Issuing Agency

In HIBCC

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

GDF

Product Code Name

Guide, Needle, Surgical

Public Device Record Key

cbfdf399-758e-4f2e-98f8-e5c4a762b0cf

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

February 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-