Catalog Number

-

Brand Name

Cirona

Version/Model Number

6100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130571,K130571

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

7e796dcc-b9e7-4937-9541-21092b9d775b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2016

Package DI Number

10879766005423

Quantity per Package

1

Contains DI Package

00879766005426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case