Hero - HERO DBM+ PUTTY, 10CC - SPINAL ELEMENTS, INC.

Duns Number:610712213

Device Description: HERO DBM+ PUTTY, 10CC

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More Product Details

Catalog Number

-

Brand Name

Hero

Version/Model Number

01004-010

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

-

Product Code Details

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Device Record Status

Public Device Record Key

a2727b57-8141-41bb-a0ba-276b3094715a

Public Version Date

August 16, 2019

Public Version Number

4

DI Record Publish Date

July 08, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINAL ELEMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4289
2 A medical device with a moderate to high risk that requires special controls. 2600