PLEXUR P® - GRANULES 60000030 PLEXUR P 30 CC - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: GRANULES 60000030 PLEXUR P 30 CC

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More Product Details

Catalog Number

-

Brand Name

PLEXUR P®

Version/Model Number

60000030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 08, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

FDA Premarket Submission

K080511

Product Code Details

Product Code

MBP

Product Code Name

Filler, bone void, osteoinduction (w/o human growth factor)

Device Record Status

Public Device Record Key

86065e20-7bdb-4ba0-8479-0d0a2842fbf2

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

July 20, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC SOFAMOR DANEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13352
2 A medical device with a moderate to high risk that requires special controls. 26085
3 A medical device with high risk that requires premarket approval 190
U Unclassified 75