Catalog Number

SW100

Brand Name

DURAKNOT

Version/Model Number

SW100

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

K972679,K972679,K972679

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

7267e7fa-72ad-4acf-8fee-497cb278d219

Public Version Date

November 12, 2021

Public Version Number

5

DI Record Publish Date

July 15, 2016

Package DI Number

30705036002882

Quantity per Package

12

Contains DI Package

10705036002888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE