Catalog Number

ER GUIDE 1005

Brand Name

OcciGuide

Version/Model Number

048-1001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

582b4067-6d8f-4dd7-8019-7f9bb95cc041

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

February 25, 2021

Package DI Number

M710ERGUIDE10052

Quantity per Package

5

Contains DI Package

M710ERGUIDE10050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf carton