Catalog Number

XL-11

Brand Name

ORC TYPE XL-11

Version/Model Number

18 GA x 11"

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"

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

b61c32b2-55f1-445e-8b49-224a92ce920d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 04, 2017

Package DI Number

20858690006321

Quantity per Package

6

Contains DI Package

10858690006324

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case