Catalog Number

8535C

Brand Name

Curity

Version/Model Number

8535C

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

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

2ed14474-0b02-4ef8-be05-49f500e2cede

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

June 29, 2018

Package DI Number

10884521109407

Quantity per Package

60

Contains DI Package

20884521109404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE