Catalog Number

X-81522P

Brand Name

Transluma ISO#100 Post 5ea Pkg

Version/Model Number

X-81522P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 10, 2020

Issuing Agency

In HIBCC

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

ELR

Product Code Name

POST, ROOT CANAL

Public Device Record Key

64dbea1d-99cc-43e6-bed0-b87076925f79

Public Version Date

September 25, 2020

Public Version Number

3

DI Record Publish Date

November 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-