Peacock Tanning - Suntan Unit. One Panel with ten 72" suntan lamps. - Medtek Lighting Corporation

Duns Number:002692106

Device Description: Suntan Unit. One Panel with ten 72" suntan lamps. Panel is wall mounted.

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More Product Details

Catalog Number

1000HT

Brand Name

Peacock Tanning

Version/Model Number

1000HT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

LEJ

Product Code Name

Booth, Sun Tan

Device Record Status

Public Device Record Key

ef6a3879-394f-4fc4-b796-76b0c461734c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEK LIGHTING CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21
U Unclassified 3