Laparoscope - SOPRO-COMEG GmbH

Duns Number:507185952

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More Product Details

Catalog Number

-

Brand Name

Laparoscope

Version/Model Number

162 053 150

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

K945266

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

f4f415ed-4899-4b74-abf2-d2335107b3f1

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOPRO-COMEG GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1769