Catalog Number

-

Brand Name

Laborie

Version/Model Number

DIS130

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

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

040bc2cf-d129-4404-bbe3-2e1c45409fab

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

June 08, 2017

Package DI Number

35019517099458

Quantity per Package

25

Contains DI Package

15019517099454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE