Galea Elevator - The Galea Elevator is a stainless-steel, - ARKIS BIOSCIENCES INC.

Duns Number:078846878

Device Description: The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue.

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More Product Details

Catalog Number

41.312.101

Brand Name

Galea Elevator

Version/Model Number

41.312.101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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 Details

Product Code

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

af7842bf-90b8-4f0b-90ce-2adf7903614b

Public Version Date

July 27, 2022

Public Version Number

5

DI Record Publish Date

April 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARKIS BIOSCIENCES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 2