Catalog Number

TRP164

Brand Name

FASSIER-DUVAL TELESCOPIC IM SYSTEM

Version/Model Number

TRP164

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HWK

Product Code Name

TREPHINE

Public Device Record Key

8bc583f0-db2e-46d1-9c55-3b4691dbb96f

Public Version Date

July 30, 2020

Public Version Number

2

DI Record Publish Date

May 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-