Catalog Number

VMCH-D

Brand Name

VELOCITY ALPHA ™

Version/Model Number

Craniotome head for VMN-C1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K191479

Product Code

HBE

Product Code Name

Drills, Burrs, Trephines & Accessories (Simple, Powered)

Public Device Record Key

b1d1ce24-eab4-477c-966c-b382c55edc0f

Public Version Date

June 18, 2021

Public Version Number

1

DI Record Publish Date

June 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-