PRO-DENSE™ - WRIGHT MEDICAL TECHNOLOGY, INC.

Duns Number:807201207

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More Product Details

Catalog Number

87SR0020

Brand Name

PRO-DENSE™

Version/Model Number

87SR0020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Device Record Status

Public Device Record Key

f4eb49d4-9b17-415a-a220-4be8f0f51457

Public Version Date

May 17, 2022

Public Version Number

2

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WRIGHT MEDICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1994
2 A medical device with a moderate to high risk that requires special controls. 5554