Catalog Number

-

Brand Name

CONMED

Version/Model Number

SB1057

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

-

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

db845b7e-928b-47cd-9467-cc13c7981d4e

Public Version Date

February 17, 2020

Public Version Number

2

DI Record Publish Date

December 17, 2019

Package DI Number

24714127860675

Quantity per Package

10

Contains DI Package

14714127860678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton