Catalog Number

610-2381

Brand Name

Drape

Version/Model Number

610-2381

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K970513,K970513

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

b5203651-b8d1-45d8-a83d-ba9206b4960a

Public Version Date

January 29, 2021

Public Version Number

1

DI Record Publish Date

January 21, 2021

Package DI Number

00841436120876

Quantity per Package

24

Contains DI Package

10841436120873

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-