RTS Lesser MTP Implant - Instruments - IN2BONES USA, LLC

Duns Number:079700711

Device Description: Instruments

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More Product Details

Catalog Number

-

Brand Name

RTS Lesser MTP Implant

Version/Model Number

M04 S0001

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

-

Product Code Details

Product Code

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

5742ee61-8fe6-4c17-8a16-bb368465d60b

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

March 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IN2BONES USA, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113
2 A medical device with a moderate to high risk that requires special controls. 1255