Catalog Number

-

Brand Name

EndoWrist

Version/Model Number

41645B

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"

Yes

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

8d3435c3-ae94-4a60-88fb-95c4887985b4

Public Version Date

March 02, 2020

Public Version Number

6

DI Record Publish Date

July 08, 2016

Package DI Number

10886874112813

Quantity per Package

12

Contains DI Package

00886874112816

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX