Vitoss - Bone Graft Substitute, 1-4mm Morsels Filled - Stryker Corporation

Duns Number:149183167

Device Description: Bone Graft Substitute, 1-4mm Morsels Filled Canister, Beta-Tricalcium Phosphate

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More Product Details

Catalog Number

2102-0033

Brand Name

Vitoss

Version/Model Number

2102-0033

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

K032130

Product Code Details

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Device Record Status

Public Device Record Key

a2666217-ecf6-4bab-81d7-9ad516e1f33e

Public Version Date

November 03, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2688
2 A medical device with a moderate to high risk that requires special controls. 5304
3 A medical device with high risk that requires premarket approval 86