Catalog Number

-

Brand Name

Intervertebral Disc Preparation Instruments

Version/Model Number

256-15-100-1616

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

HTQ

Product Code Name

BROACH

Public Device Record Key

5213bf3f-14b0-46e5-90db-739cb06f0f30

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-