Ultra Vac - Ultra Vac Smoke Evacuation Pencil, E-Z Clean - MEGADYNE MEDICAL PRODUCTS, INC.

Duns Number:185444825

Device Description: Ultra Vac Smoke Evacuation Pencil, E-Z Clean Non-stick Electrode, 9 Ft Tubing

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More Product Details

Catalog Number

-

Brand Name

Ultra Vac

Version/Model Number

2110-09

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Device Record Status

Public Device Record Key

6e8fe68f-f26b-4eb4-822b-9a2872f26311

Public Version Date

December 31, 2021

Public Version Number

8

DI Record Publish Date

December 14, 2016

Additional Identifiers

Package DI Number

30614559101982

Quantity per Package

20

Contains DI Package

10614559101988

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"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