NA - MODULE-SAFETY 600g BLACK 10PK - LANCER ORTHODONTICS, INC.

Duns Number:045545589

Device Description: MODULE-SAFETY 600g BLACK 10PK

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

830-607RM

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

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Device Record Status

Public Device Record Key

28ba0754-8fb3-46ef-b278-679e291e4d2f

Public Version Date

April 18, 2022

Public Version Number

4

DI Record Publish Date

January 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LANCER ORTHODONTICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 481