Catalog Number

-

Brand Name

Auto Suture

Version/Model Number

1011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 03, 2020

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

K944249,K944249

Product Code

FEB

Product Code Name

ACCESSORIES, CLEANING, FOR ENDOSCOPE

Public Device Record Key

9ada27d4-4f4a-42ea-9d7d-59beef8ea189

Public Version Date

September 09, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884521066394

Quantity per Package

20

Contains DI Package

10884521066397

Package Discontinue Date

November 03, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE