Catalog Number

-

Brand Name

ACMI Seal Self Sealing For Accessories up to 7 FR (2.33 mm)

Version/Model Number

CS-W7S

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

K012758,K012758

Product Code

FGB

Product Code Name

Ureteroscope and accessories, flexible/rigid

Public Device Record Key

5dc57484-a9b9-4251-b7cb-1f212082aaeb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

00821925001220

Quantity per Package

6

Contains DI Package

00821925036352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-