Catalog Number

-

Brand Name

Surgical Guide

Version/Model Number

FLSGAM01

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)

-

Over the Counter (OTC)

Yes

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

2a481aa0-7cc4-4dd6-ba1b-79952cd90605

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

November 27, 2019

Package DI Number

00860002099316

Quantity per Package

8

Contains DI Package

00860002099309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case