Catalog Number

SRI-0205005

Brand Name

Surgical Guide 2

Version/Model Number

SRI-0205005

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

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

a1f895f5-8abc-45d4-9f83-13d89392b9bb

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

Package DI Number

10850039704021

Quantity per Package

1

Contains DI Package

00850039704024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box