VASER - CANISTER, 1250CC, CASE 20, VENTX - SOLTA MEDICAL

Duns Number:079999584

Device Description: CANISTER, 1250CC, CASE 20, VENTX

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More Product Details

Catalog Number

130-0168

Brand Name

VASER

Version/Model Number

130-0168

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

-

Product Code Details

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Device Record Status

Public Device Record Key

6f66d317-6975-45a9-9eb9-5ba7a94e9407

Public Version Date

November 05, 2018

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOLTA MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61
2 A medical device with a moderate to high risk that requires special controls. 396