ACUZONE - Hansol Medical Co.

Duns Number:557793906

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More Product Details

Catalog Number

-

Brand Name

ACUZONE

Version/Model Number

ACUZONE PREMIUM CUPPING SET

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

KNM

Product Code Name

Device, Pressure Applying

Device Record Status

Public Device Record Key

f9bb3b60-ea60-4635-9d78-2ea67687f311

Public Version Date

April 23, 2020

Public Version Number

2

DI Record Publish Date

August 09, 2019

Additional Identifiers

Package DI Number

18809118711063

Quantity per Package

10

Contains DI Package

08809118711066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box

"HANSOL MEDICAL CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 20