Catalog Number

-

Brand Name

FAST SPLINT MATRIX

Version/Model Number

FSM18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2021

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102207,K102207

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

0d3e7a5e-f021-475b-9724-c042c54a6637

Public Version Date

July 27, 2021

Public Version Number

4

DI Record Publish Date

November 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-