Medetz Surgical Instruments - Osteotomy Guide - MapLog - Medetz Surgical Instruments LLC

Duns Number:876570990

Device Description: Osteotomy Guide - MapLog

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More Product Details

Catalog Number

-

Brand Name

Medetz Surgical Instruments

Version/Model Number

wr-rogmap

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

2c2baa67-4381-41a5-a6d9-4b5582abb72f

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDETZ 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 120