Catalog Number

-

Brand Name

Auto Suture

Version/Model Number

OMST12BTNL

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

K924011,K924011

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

68f5afd2-ff8f-43a3-98cb-c74e2f8026ea

Public Version Date

October 12, 2022

Public Version Number

4

DI Record Publish Date

June 22, 2017

Package DI Number

20884521552446

Quantity per Package

5

Contains DI Package

10884521552449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK