Catalog Number

-

Brand Name

LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter

Version/Model Number

490-00183-02, 490-00189-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 21, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K163510

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

04062d4f-97b4-4491-b2c8-0ab9398fd33e

Public Version Date

December 22, 2020

Public Version Number

2

DI Record Publish Date

September 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-