SHARPER IMAGE - CALMING HEAT WEIGHTED MASSAGING HEATING PAD - Zhejiang Lumeng Health & Technology Co., Ltd.

Duns Number:421341654

Device Description: CALMING HEAT WEIGHTED MASSAGING HEATING PAD

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More Product Details

Catalog Number

-

Brand Name

SHARPER IMAGE

Version/Model Number

31581

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

IRT

Product Code Name

Pad, Heating, Powered

Device Record Status

Public Device Record Key

d0293620-95df-41e6-9c38-15eefc746c35

Public Version Date

March 29, 2022

Public Version Number

3

DI Record Publish Date

November 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZHEJIANG LUMENG HEALTH & TECHNOLOGY 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. 29