Collage - Osteoconductive Scaffold Strip 10 cc - ORTHOFIX INC.

Duns Number:927083808

Device Description: Osteoconductive Scaffold Strip 10 cc

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More Product Details

Catalog Number

-

Brand Name

Collage

Version/Model Number

711010

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"

Yes

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

K063124

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

64136412-8ab9-42fa-b311-50d5152af663

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOFIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2497
2 A medical device with a moderate to high risk that requires special controls. 5891
3 A medical device with high risk that requires premarket approval 104