Catalog Number

99017

Brand Name

Curity

Version/Model Number

99017

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

9a0c1a11-7e3a-48e4-901b-09200b0560d0

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Package DI Number

20884521072272

Quantity per Package

20

Contains DI Package

10884521072275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE