Wonder Double Head TDP Heat Lamp - This lamp features a proprietary mineral plate to - Holly Prime Corp

Duns Number:080445043

Device Description: This lamp features a proprietary mineral plate to emit far infrared band

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More Product Details

Catalog Number

-

Brand Name

Wonder Double Head TDP Heat Lamp

Version/Model Number

L11

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

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

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

bbab3b7f-a325-4651-976c-a17c3617543f

Public Version Date

August 31, 2022

Public Version Number

2

DI Record Publish Date

January 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOLLY PRIME CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4