VS3 Iridium Endoscope-IR 5.5mm, Long, 0°, Standard FOV - Refurbished - VISIONSENSE LTD.

Duns Number:532199478

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More Product Details

Catalog Number

153-0051RFB

Brand Name

VS3 Iridium Endoscope-IR 5.5mm, Long, 0°, Standard FOV - Refurbished

Version/Model Number

VS3-IR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 15, 2022

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152204

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

f2084b14-8c2b-4aac-816d-3161e1a1229d

Public Version Date

February 16, 2022

Public Version Number

2

DI Record Publish Date

April 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISIONSENSE LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 77