Cyber Blade - Battery powered Motor for Cyber Blade morcellator - SIDAM SRL

Duns Number:443780226

Device Description: Battery powered Motor for Cyber Blade morcellator

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More Product Details

Catalog Number

-

Brand Name

Cyber Blade

Version/Model Number

20042001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K192499

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

6a7f63a9-1316-413c-8fee-078d1397983d

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIDAM SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2