Phantom - Surgical Aspirator: 1/3 hp. 0-8.0 scfm / 0-29.8 - Innovative Med

Duns Number:928308407

Device Description: Surgical Aspirator: 1/3 hp. 0-8.0 scfm / 0-29.8 in. hg. @ sea level, 230 VAC

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More Product Details

Catalog Number

IM-K2550-2

Brand Name

Phantom

Version/Model Number

2550-2

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

K895761

Product Code Details

Product Code

JCX

Product Code Name

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Device Record Status

Public Device Record Key

ed2e50ba-35db-4e8b-aa14-ac75af0fe7e5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVATIVE MED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 13