Catalog Number

-

Brand Name

I-GEL SUPRAGLOTTIC AIRWAY, SIZE 1

Version/Model Number

8201000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Public Device Record Key

b610b797-8b3b-4b36-bfb9-e8b1f6de3096

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 19, 2021

Package DI Number

05030267090846

Quantity per Package

10

Contains DI Package

05030267076208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-