Catalog Number

STEICA4845-01

Brand Name

Sustainable Technologies

Version/Model Number

STEICA4845-01

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)

Yes

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

K172647,K172647,K172647

Product Code

NUJ

Product Code Name

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Public Device Record Key

a52106da-c743-4f44-91b9-9088f19162f3

Public Version Date

June 28, 2021

Public Version Number

6

DI Record Publish Date

December 13, 2019

Package DI Number

10810041632408

Quantity per Package

1

Contains DI Package

00810041632401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box