Catalog Number

-

Brand Name

Cirona

Version/Model Number

D-125

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

K141578,K141578

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

20f868d7-4b7c-4492-ac73-6a5b1eddab59

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2016

Package DI Number

10879766005300

Quantity per Package

10

Contains DI Package

00879766005303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case