Advanced Wart Freeze - Advanced Wart Freeze 8 applications - Aso LLC

Duns Number:152793493

Device Description: Advanced Wart Freeze 8 applications

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More Product Details

Catalog Number

-

Brand Name

Advanced Wart Freeze

Version/Model Number

017276237313

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

4cb9307f-5307-4082-bdaa-67429e413719

Public Version Date

July 23, 2021

Public Version Number

2

DI Record Publish Date

September 20, 2020

Additional Identifiers

Package DI Number

10017276237310

Quantity per Package

6

Contains DI Package

00017276237313

Package Discontinue Date

April 26, 2021

Package Status

Not in Commercial Distribution

Package Type

case

"ASO LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48
2 A medical device with a moderate to high risk that requires special controls. 4
U Unclassified 1