Catalog Number

9-6100-01-002

Brand Name

IsoTis Cervical Facet Prep Instruments

Version/Model Number

9-6100-01-002

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"

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)

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

Orthopedic manual surgical instrument

Public Device Record Key

5089444f-0a05-45e6-87df-c822ed38fc3f

Public Version Date

February 16, 2022

Public Version Number

2

DI Record Publish Date

January 31, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-