Catalog Number

-

Brand Name

Britedent

Version/Model Number

BSI-5101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

a4ef0ca5-9cee-4194-8f49-cb2c8c018269

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 31, 2021

Package DI Number

D974BSI51012

Quantity per Package

50

Contains DI Package

D974BSI51011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag