Catalog Number

AS-iFS2

Brand Name

AIRSEAL

Version/Model Number

AS-iFS2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 2021

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

-

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

HIF

Product Code Name

INSUFFLATOR, LAPAROSCOPIC

Public Device Record Key

b711012f-56c7-47e5-bf08-687b7ded92b3

Public Version Date

September 09, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-