MEDINAUT MAX - MEDINAUT MAX Reamer Attachment - IMEDICOM CO., LTD.

Duns Number:690340653

Device Description: MEDINAUT MAX Reamer Attachment

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More Product Details

Catalog Number

-

Brand Name

MEDINAUT MAX

Version/Model Number

BMA-R10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 22, 2021

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

KIJ

Product Code Name

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

Device Record Status

Public Device Record Key

4ea0d23c-133b-4459-9c14-8f7ff2b7f8c2

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMEDICOM CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2527
2 A medical device with a moderate to high risk that requires special controls. 59