Catalog Number

81010

Brand Name

NA

Version/Model Number

MIC81010

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

-

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

b8b227d3-ebe0-4ac2-bdc3-d8ed6a36d4a9

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

June 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-