Catalog Number

-

Brand Name

SurgyPad

Version/Model Number

780-420

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

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

da48c8ca-a212-4abb-87ef-58054994da56

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

November 26, 2019

Package DI Number

00810014630014

Quantity per Package

5

Contains DI Package

00810014630007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box