Catalog Number

-

Brand Name

MITEK SPORTS MEDICINE

Version/Model Number

278015

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Public Device Record Key

d9b95d61-162e-4605-96d0-08bae4e16cab

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Package DI Number

20815634020041

Quantity per Package

5

Contains DI Package

10815634020044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE