Catalog Number

106450

Brand Name

Remotely Operated Suction & Irrigation Tubing Set, Box

Version/Model Number

106450

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"

-

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

K141323,K141323

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

c577e848-1a20-4ce9-8edd-142b19dbf5f1

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

February 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-