Catalog Number

D1005

Brand Name

LAP-13-4

Version/Model Number

D1005

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)

-

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

d7c1d5ac-2a00-4f18-98c7-b37aee49883c

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

November 11, 2016

Package DI Number

10842102105088

Quantity per Package

6

Contains DI Package

00842102105081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case