Catalog Number

M.27.15.D448

Brand Name

StecoGuide

Version/Model Number

M.27.15.D448

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

96e8fc43-3345-4309-9f6d-7d048fb01ee6

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

May 01, 2018

Package DI Number

M2715D4482

Quantity per Package

5

Contains DI Package

ESTOM2715D4480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

foil pouch