Catalog Number

81010-6

Brand Name

MicroAire®

Version/Model Number

81010-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K211297,K211297

Product Code

EMF

Product Code Name

Knife, Surgical

Public Device Record Key

ab6e2bfd-0803-4c35-8f81-dc9b8e5a172d

Public Version Date

June 23, 2022

Public Version Number

1

DI Record Publish Date

June 15, 2022

Package DI Number

10847399017236

Quantity per Package

6

Contains DI Package

00847399017239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK