Catalog Number

TRH30

Brand Name

PROXIMATE

Version/Model Number

TRH30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

900c2f19-17d2-4cae-9504-b308446214e5

Public Version Date

October 16, 2019

Public Version Number

5

DI Record Publish Date

August 24, 2015

Package DI Number

40705036013298

Quantity per Package

240

Contains DI Package

10705036013297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE