Catalog Number

-

Brand Name

Regard

Version/Model Number

OB00100Y

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

OHM

Product Code Name

Cesarean Section Tray

Public Device Record Key

e7485548-6940-4feb-81fc-d2f5d3df8140

Public Version Date

April 08, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2020

Package DI Number

20194717108778

Quantity per Package

2

Contains DI Package

10194717108771

Package Discontinue Date

April 08, 2021

Package Status

Not in Commercial Distribution

Package Type

-