Catalog Number

CRY01-H4-1E

Brand Name

Precision Screw

Version/Model Number

CRY01-H4-1E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

c65f633e-beda-4070-bd1e-cdbe0bea5489

Public Version Date

December 14, 2020

Public Version Number

4

DI Record Publish Date

December 10, 2018

Package DI Number

19351290000088

Quantity per Package

10

Contains DI Package

09351290000081

Package Discontinue Date

December 07, 2020

Package Status

Not in Commercial Distribution

Package Type

-