Catalog Number

SOLA9200ST228

Brand Name

Laparoscopy Set for ROCAFLOW - 2 ways

Version/Model Number

09-0244

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

FHF

Product Code Name

System, Evacuator, Fluid

Public Device Record Key

29f82829-c451-4865-b6d6-b3dff1d2e99e

Public Version Date

April 23, 2019

Public Version Number

3

DI Record Publish Date

August 03, 2018

Package DI Number

03700512921974

Quantity per Package

60

Contains DI Package

03700512901976

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box