Catalog Number

-

Brand Name

Adjustable Biopsy Port Seal

Version/Model Number

BPS-A

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

K012929,K012929

Product Code

FAJ

Product Code Name

Cystoscope and accessories, flexible/rigid

Public Device Record Key

15d7af14-854d-44c1-a857-c6542c3121ba

Public Version Date

July 09, 2019

Public Version Number

6

DI Record Publish Date

October 13, 2016

Package DI Number

00821925027312

Quantity per Package

5

Contains DI Package

00821925031500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-