LAPAROSCOPIC TUBING - Megadyne Laparoscopic Tubing - MEGADYNE MEDICAL PRODUCTS, INC.

Duns Number:185444825

Device Description: Megadyne Laparoscopic Tubing

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More Product Details

Catalog Number

2390J

Brand Name

LAPAROSCOPIC TUBING

Version/Model Number

2390J

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

Yes

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

-

Product Code Details

Product Code

FCZ

Product Code Name

TUBE, SMOKE REMOVAL, ENDOSCOPIC

Device Record Status

Public Device Record Key

26c28212-34b2-446d-846b-484ed4ebf677

Public Version Date

April 20, 2022

Public Version Number

8

DI Record Publish Date

August 11, 2020

Additional Identifiers

Package DI Number

30614559104594

Quantity per Package

25

Contains DI Package

10614559104590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"MEGADYNE MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 219