Catalog Number

DEF1088

Brand Name

Defries Industries

Version/Model Number

DEF1088

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211969,K211969

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

8061f3fa-7040-46e8-a62a-1f15de25a111

Public Version Date

December 17, 2021

Public Version Number

1

DI Record Publish Date

December 09, 2021

Package DI Number

00850033380965

Quantity per Package

100

Contains DI Package

00850033380958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case