Catalog Number

35.003.02

Brand Name

Uretero-Renoscope,430mm,rigid,distal end 7.5/10Ch.,work.channel 1.67x1.85mm(5Ch)

Version/Model Number

35.003.02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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"

Yes

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

-

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

f8e22fff-689d-469d-bec4-8b0c9b7d6a1b

Public Version Date

February 28, 2019

Public Version Number

1

DI Record Publish Date

January 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-