A Li Gator - GENICON, INC.

Duns Number:079805400

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More Product Details

Catalog Number

-

Brand Name

A Li Gator

Version/Model Number

360-010-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 29, 2020

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FZP

Product Code Name

Clip, Implantable

Device Record Status

Public Device Record Key

4680c5c0-dbdb-4e5b-8661-51d98d2f4b81

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

May 05, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENICON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 159
2 A medical device with a moderate to high risk that requires special controls. 88