SCANLAN® Minimally Invasive Instrumentation - SCANLAN® Minimally Invasive Suction Instrument - SCANLAN INTERNATIONAL INC

Duns Number:023055619

Device Description: SCANLAN® Minimally Invasive Suction Instrument

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More Product Details

Catalog Number

9009-915-03

Brand Name

SCANLAN® Minimally Invasive Instrumentation

Version/Model Number

9009-915-03

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

K945474

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

59361933-9b6e-4df5-8c5b-7886e7b94022

Public Version Date

May 27, 2020

Public Version Number

1

DI Record Publish Date

May 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCANLAN INTERNATIONAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1949
2 A medical device with a moderate to high risk that requires special controls. 855