Catalog Number

-

Brand Name

HF CBL 4mm MAR/BER/AES/ACMI

Version/Model Number

166 A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2017

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

-

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

K971881

Product Code

FJL

Product Code Name

RESECTOSCOPE

Public Device Record Key

9aa3a519-5af2-4896-8105-8b921eb5af7c

Public Version Date

October 06, 2022

Public Version Number

4

DI Record Publish Date

May 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-