GammaPro Standard Probe with Tablet Carry Case - GammaPro Kit with Standard probe, Tablet and - Kubtec

Duns Number:361955128

Device Description: GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiati GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.

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More Product Details

Catalog Number

-

Brand Name

GammaPro Standard Probe with Tablet Carry Case

Version/Model Number

K0018C02

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)

Yes

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

IZD

Product Code Name

Probe, Uptake, Nuclear

Device Record Status

Public Device Record Key

78893344-7fcd-4538-ad96-83ec90a35b4f

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KUBTEC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 6