Catalog Number

220497A

Brand Name

Micro iBlade

Version/Model Number

220497A

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"

Yes

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

GES

Product Code Name

Blade, Scalpel

Public Device Record Key

5dcc0f7b-6984-448f-80c2-e05f42c6fc15

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

November 07, 2016

Package DI Number

20857595005446

Quantity per Package

10

Contains DI Package

00857595005442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-