Catalog Number

901039

Brand Name

FS Ergo

Version/Model Number

KFS-1-M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2019

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

K173646

Product Code

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Public Device Record Key

4cb00c2d-b485-4410-9e7a-5ddae74fe54a

Public Version Date

January 27, 2020

Public Version Number

4

DI Record Publish Date

January 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-