MicroAire® - SST BUR, LINDEMANN, 4 Flutes x 2.2mm Dia. - Microaire Surgical Instruments LLC

Duns Number:103056420

Device Description: SST BUR, LINDEMANN, 4 Flutes x 2.2mm Dia.

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More Product Details

Catalog Number

-

Brand Name

MicroAire®

Version/Model Number

K-22NS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Product Code Details

Product Code

LXZ

Product Code Name

Guard, Instrument

Device Record Status

Public Device Record Key

7fcd0b6e-6616-470c-9b3a-ee0e758c8d72

Public Version Date

April 07, 2022

Public Version Number

1

DI Record Publish Date

March 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROAIRE SURGICAL INSTRUMENTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 756
2 A medical device with a moderate to high risk that requires special controls. 190