NUGABEST - Personal heating therapeutic device - Nuga Medical Co.,Ltd.

Duns Number:690034673

Device Description: Personal heating therapeutic device

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More Product Details

Catalog Number

T20P-DM-11-2-022-01A-0

Brand Name

NUGABEST

Version/Model Number

T20P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 07, 2025

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

Yes

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

IRT

Product Code Name

Pad, Heating, Powered

Device Record Status

Public Device Record Key

878a278e-e7f5-460e-8c45-a037e1dc8c9e

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUGA MEDICAL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2