Delasco SaftEvac - Smoke Evacuator Unit and one filter pack, 110 - DERMATOLOGIC LAB AND SUPPLY, INC.

Duns Number:021628771

Device Description: Smoke Evacuator Unit and one filter pack, 110 Volt. Overall Dimensions: 11″ W × 12″ H × 1 Smoke Evacuator Unit and one filter pack, 110 Volt. Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted

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More Product Details

Catalog Number

EV

Brand Name

Delasco SaftEvac

Version/Model Number

EV

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

-

Product Code Details

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Device Record Status

Public Device Record Key

8bf6b384-e138-4339-b0e9-9888484b0ad0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DERMATOLOGIC LAB AND SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 90