Logic - Laparoscopic Instrument System - 355mm Petelin - SURGICAL INNOVATIONS LIMITED

Duns Number:771051935

Device Description: 355mm Petelin

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More Product Details

Catalog Number

-

Brand Name

Logic - Laparoscopic Instrument System

Version/Model Number

101-49029

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111986

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

1783cc82-daf1-4eda-9e0b-7a7fa41ec663

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURGICAL INNOVATIONS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 335