Catalog Number

017447

Brand Name

Cystoscopic Irrigation Bag

Version/Model Number

017447

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

-

Product Code

KOA

Product Code Name

SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Public Device Record Key

7ee087e2-0072-453c-8f5c-4994cfe03649

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

10801741049108

Quantity per Package

50

Contains DI Package

00801741049101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA