Catalog Number

382952

Brand Name

Regard™

Version/Model Number

BFCAP24-REG

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

91281434-b5a8-475d-abff-8185a77938f9

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 14, 2020

Package DI Number

10326053117487

Quantity per Package

750

Contains DI Package

00326053117480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-