Dickson Paraffin Bath - PB104-PARAFFIN BATH 220V ISRAEL CORD - Whitehall Manufacturing Co

Duns Number:008312423

Device Description: PB104-PARAFFIN BATH 220V ISRAEL CORD

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More Product Details

Catalog Number

PB104BCORD4

Brand Name

Dickson Paraffin Bath

Version/Model Number

PB-104B-CORD4

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IMC

Product Code Name

Bath, Paraffin

Device Record Status

Public Device Record Key

f641706d-da0b-4d93-8fa8-507942733ce8

Public Version Date

December 13, 2018

Public Version Number

1

DI Record Publish Date

November 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WHITEHALL MANUFACTURING CO" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 157
2 A medical device with a moderate to high risk that requires special controls. 296