MTM® - Starter MTM® Kit - RAINTREE ESSIX INC.

Duns Number:801157132

Device Description: Starter MTM® Kit

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

82LKIT

Brand Name

MTM®

Version/Model Number

82LKIT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 14, 2019

Issuing Agency

In HIBCC

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"

Yes

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

-

Product Code Details

Product Code

NXC

Product Code Name

Aligner, sequential

Device Record Status

Public Device Record Key

8f20b062-1130-42f7-8bc5-255da5a342c9

Public Version Date

May 14, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RAINTREE ESSIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 103
U Unclassified 13