N/A - Composite Twin ROTH .022 LO4 -17°T 0°A 5PK - FLEXMEDICS

Duns Number:028853567

Device Description: Composite Twin ROTH .022 LO4 -17°T 0°A 5PK

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

45-L4-2U-V

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

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

K973776,K973776

Product Code Details

Product Code

DYW

Product Code Name

Bracket, Plastic, Orthodontic

Device Record Status

Public Device Record Key

abde82fd-b485-48ef-9747-a6bf92338279

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXMEDICS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 923