Reveal® - Reveal® Retainers 4 Trays - ORTHO ORGANIZERS, INC.

Duns Number:062165188

Device Description: Reveal® Retainers 4 Trays

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More Product Details

Catalog Number

-

Brand Name

Reveal®

Version/Model Number

135-RET4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

NXC

Product Code Name

Aligner, sequential

Device Record Status

Public Device Record Key

e19e27f8-4c17-4928-a877-e8cb523de01b

Public Version Date

October 25, 2022

Public Version Number

1

DI Record Publish Date

October 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO ORGANIZERS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8511
2 A medical device with a moderate to high risk that requires special controls. 1527