Percusys® Plus - Percusys® Plus Rod Ti-Alloy - Joimax GmbH

Duns Number:344267187

Device Description: Percusys® Plus Rod Ti-Alloy

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More Product Details

Catalog Number

JMPP6060RS

Brand Name

Percusys® Plus

Version/Model Number

JMPP6060RS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K192680

Product Code Details

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

e59fa693-bdae-4a56-85b5-e690591052fb

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JOIMAX GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 293