Britedent - (4.25" x 12") Sterilization Pouches - Bright Supply, Inc.

Duns Number:124117012

Device Description: (4.25" x 12") Sterilization Pouches

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More Product Details

Catalog Number

-

Brand Name

Britedent

Version/Model Number

BSI-1243

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Device Record Status

Public Device Record Key

32e085c5-de03-4c47-854a-48ccea874371

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 18, 2022

Additional Identifiers

Package DI Number

D974BSI12432

Quantity per Package

10

Contains DI Package

D974BSI12431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BRIGHT SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 2