Catalog Number

-

Brand Name

Cirona

Version/Model Number

F-10

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"

Yes

For Single-Use

Yes

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

K131743,K131743

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

d475f7b4-bdf5-4b27-9a15-95af48a070ca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2016

Package DI Number

10879766005263

Quantity per Package

10

Contains DI Package

00879766005266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case