MicroAire® - INSTRUMENT CABLE, 5401 PEDAL TO 5020/5025 - Microaire Surgical Instruments LLC

Duns Number:103056420

Device Description: INSTRUMENT CABLE, 5401 PEDAL TO 5020/5025

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


More Product Details

Catalog Number

-

Brand Name

MicroAire®

Version/Model Number

5025-5401

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

-

Product Code Details

Product Code

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Device Record Status

Public Device Record Key

dff8b1f6-9908-46da-9b9d-f794b2fac2cd

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 17, 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