Catalog Number

SOLA0533ST12

Brand Name

Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip,

Version/Model Number

SOLA0533ST12

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

d6f6c097-1f7e-4579-a8c2-109a38c385df

Public Version Date

November 11, 2019

Public Version Number

6

DI Record Publish Date

October 11, 2016

Package DI Number

03700512911036

Quantity per Package

10

Contains DI Package

03700512901037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box Label