Catalog Number

-

Brand Name

EndoWrist

Version/Model Number

428080

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

K122532,K122532

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

b1c1af4d-4e7f-45ea-af36-d4886714aacb

Public Version Date

November 23, 2021

Public Version Number

6

DI Record Publish Date

August 03, 2016

Package DI Number

10886874112066

Quantity per Package

6

Contains DI Package

00886874112069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX