Catalog Number

ORC-A-18

Brand Name

ORC-A, F/G ASSY, RANFAC, 18 GA

Version/Model Number

18 GAUGE

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"

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

-

Product Code

GBZ

Product Code Name

Catheter, Cholangiography

Public Device Record Key

d0b09671-e2de-4644-9bf5-374900e699f1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 04, 2017

Package DI Number

M9796808401M9

Quantity per Package

20

Contains DI Package

M9796808401M1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case