Navigator 2.0 Control Unit N2-9800-00

GUDID 00810049840006

Dilon Technologies, Inc.

Hand-held-detector nuclear medicine system
Primary Device ID00810049840006
NIH Device Record Key0705b06d-3795-43a0-a404-d2b92085d6f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigator 2.0 Control Unit
Version Model Number2.0
Catalog NumberN2-9800-00
Company DUNS061727272
Company NameDilon Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810049840006 [Primary]

FDA Product Code

IZDProbe, Uptake, Nuclear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-02-20
Device Publish Date2022-12-08

Devices Manufactured by Dilon Technologies, Inc.

00810049840006 - Navigator 2.0 Control Unit2023-02-20
00810049840006 - Navigator 2.0 Control Unit2023-02-20
00810049840020 - Navigator Laparoscopic Probe, 10mm Wired 2023-02-20
00810049840037 - Navigator Daniel Lung Probe, 10mm Wired 2023-02-20
00810049840044 - Navigator Superficial Head & Neck Probe, 11mm Wired2023-02-20
00810049840051 - Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, Angled2023-02-20
00810049840068 - Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, Straight2023-02-20
00810049840075 - Navigator Wireless Probe, 14mm Angled2023-02-20
00810049840082 - Navigator Wireless Probe, 14mm Straight2023-02-20

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