Catalog Number

-

Brand Name

CIRCASSIST

Version/Model Number

CA-INT101M

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

K201532,K201532,K201532

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

25823f1b-e39f-462a-a75d-a9dda410dc04

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

16975298105007

Quantity per Package

10

Contains DI Package

06975298105000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton