Catalog Number

-

Brand Name

SureForm

Version/Model Number

480460

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAY

Product Code Name

System, surgical, computer controlled instrument

Public Device Record Key

37ce7cdb-2064-4908-9256-461e64998442

Public Version Date

March 02, 2020

Public Version Number

2

DI Record Publish Date

July 10, 2018

Package DI Number

10886874115647

Quantity per Package

6

Contains DI Package

00886874115640

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX