neoprobe - F18 Probe, Model 1103 - DEVICOR MEDICAL PRODUCTS, INC.

Duns Number:961832156

Device Description: F18 Probe, Model 1103

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More Product Details

Catalog Number

-

Brand Name

neoprobe

Version/Model Number

NPRF18

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)

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

87e6fe1c-0fcc-4193-a405-9ea0a20539e3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEVICOR 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 17
2 A medical device with a moderate to high risk that requires special controls. 186