DIGITAL HANDSET,IMMERSIBLE,2 METER,SF - DIGITAL HANDSET,IMMERSIBLE,2 METER,SF - CURBELL MEDICAL PRODUCTS, INC.

Duns Number:796452311

Device Description: DIGITAL HANDSET,IMMERSIBLE,2 METER,SF

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More Product Details

Catalog Number

7587

Brand Name

DIGITAL HANDSET,IMMERSIBLE,2 METER,SF

Version/Model Number

HST400-110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 2018

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

IQA

Product Code Name

System, Environmental Control, Powered

Device Record Status

Public Device Record Key

11f33518-0545-4a57-bded-c50ae206a72b

Public Version Date

August 07, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURBELL MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 478
2 A medical device with a moderate to high risk that requires special controls. 8062