PHASOR - Phasor Drill 6.35-mm diameter, ~70-mm length + - PHASOR HEALTH LLC

Duns Number:111926675

Device Description: Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version 1)

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More Product Details

Catalog Number

PH-635-70 + PH-K-1

Brand Name

PHASOR

Version/Model Number

PH-635-70 + PH-K-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 22, 2120

Issuing Agency

In HIBCC

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

Yes

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

K161704

Product Code Details

Product Code

HBE

Product Code Name

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

Device Record Status

Public Device Record Key

712f0f79-a911-48b9-b428-75f45345ed65

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

May 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHASOR HEALTH LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 39