Catalog Number

-

Brand Name

Regard

Version/Model Number

UR00098S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 08, 2021

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

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

6df6b91c-2bd3-461d-b78a-2c1ce4cb517a

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

December 09, 2020

Package DI Number

20194717108884

Quantity per Package

3

Contains DI Package

10194717108887

Package Discontinue Date

April 08, 2021

Package Status

Not in Commercial Distribution

Package Type

-