MicroAire® - SmartRelease Handpiece - Microaire Surgical Instruments LLC

Duns Number:103056420

Device Description: SmartRelease Handpiece

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MicroAire®

Version/Model Number

85014

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K211297

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

64d523ba-df53-4736-b61c-008f83190be0

Public Version Date

November 02, 2021

Public Version Number

1

DI Record Publish Date

October 25, 2021

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