Catalog Number

SMSm10000

Brand Name

Isolyser/SMSm

Version/Model Number

SMSm10000

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090157,K090157

Product Code

MMK

Product Code Name

Container, Sharps

Public Device Record Key

be493031-bfa9-4057-9661-538eff16945b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

10858629005060

Quantity per Package

2

Contains DI Package

00858629005063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case