Catalog Number

-

Brand Name

Suction Tubing Set

Version/Model Number

7-510-44

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)

Yes

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

K953162,K953162

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

1c5ab974-3a2f-483c-91f6-bd57c25e671b

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 22, 2019

Package DI Number

10817183020414

Quantity per Package

10

Contains DI Package

00817183020417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-