Catalog Number

-

Brand Name

Auto Suture

Version/Model Number

OMST10BTSNL

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"

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

K924011,K924011

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

8bb13993-4d23-43e7-a70a-dd278404a4f7

Public Version Date

October 12, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521539648

Quantity per Package

5

Contains DI Package

20884521539645

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE