NA - Laparoscope, High Definition Eye Piece style 5.5 - Medos International Sàrl

Duns Number:482661753

Device Description: Laparoscope, High Definition Eye Piece style 5.5 mm x 0 DEGREES x 430 mm

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More Product Details

Catalog Number

242638

Brand Name

NA

Version/Model Number

242638

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

K941541

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

524fca84-851a-4aa1-85fd-b12d2d1c075b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDOS INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 972
2 A medical device with a moderate to high risk that requires special controls. 6382
3 A medical device with high risk that requires premarket approval 20
U Unclassified 20