MAYFIELD HEAD HOLDER ADAPTOR - Mayfield Head Holder Adaptorinstrument Rosa One - MEDTECH

Duns Number:264502977

Device Description: Mayfield Head Holder Adaptorinstrument Rosa One 3.1 (brain application)Mayfiled head holde Mayfield Head Holder Adaptorinstrument Rosa One 3.1 (brain application)Mayfiled head holder mechanical adaptor to connect the support arm to a mayfiled head holder

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More Product Details

Catalog Number

ROSAS00325

Brand Name

MAYFIELD HEAD HOLDER ADAPTOR

Version/Model Number

174013-01

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

K200511

Product Code Details

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

Public Device Record Key

ea5263dc-4d13-4db0-a225-4c2fcdd61ca4

Public Version Date

July 12, 2022

Public Version Number

3

DI Record Publish Date

September 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTECH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 251