Catalog Number

-

Brand Name

SGM-ER16i

Version/Model Number

SGM-ER16i

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KMW

Product Code Name

HANDPIECE, ROTARY BONE CUTTING

Public Device Record Key

89a007fd-5e4f-49e7-94a7-f219b78bf849

Public Version Date

April 14, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-