Catalog Number

SOLA2500ST12

Brand Name

Laparoscopy - 2 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip)

Version/Model Number

SOLA2500ST12

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

8ede1ca4-bb16-43a0-9ebb-c21b320cd4a5

Public Version Date

November 11, 2019

Public Version Number

6

DI Record Publish Date

October 11, 2016

Package DI Number

03700512921059

Quantity per Package

4

Contains DI Package

03700512911050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2