Catalog Number

-

Brand Name

Auto Suture

Version/Model Number

24055

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

K981941,K981941

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

f07a8d75-f076-48aa-b8d6-76c4a054ee1d

Public Version Date

October 12, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884521545134

Quantity per Package

5

Contains DI Package

10884521545137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE