FDA.reportPublic FDA data

TruNode

Primary DI
15420045514416
Brand
TruNode
Company
Hologic, Inc.
Model
120-807606
Catalog number
120-807606
Device description
A user feedback unit which communicates with a probe and provides a visual display, sound feedback, and controls for operating the probe.
Published
2021-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZDProbe, uptake, nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZDProbe, Uptake, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045514416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551441615420045514416

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held-detector nuclear medicine systemAn assembly of diagnostic devices comprising a hand-held, non-imaging system designed primarily to detect, record, quantify and analyse various radioactive emissions (gamma, alpha, beta) of injected or ingested radiopharmaceuticals, radiation emitting devices, or other materials. It is frequently used in the monitoring and detection of deep vein thrombosis (DVT), in surgical procedures requiring radionuclide localization and in some radiolabeled monoclonal antibody applications. It often has special software or accessory features that distinguish them from similar devices used for radiation protection purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103615NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
00841911103622NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
B619K0018C01UP0GammaPro Straight Standard ProbeKubtecIZD2025-03-26
B619K0019C01UW0GammaPro High Sensitivity ProbeKubtecIZD2025-03-26
B619K0020C01TA0GammaPro Laparoscopic ProbeKubtecIZD2025-03-26
B619K0021C01TH0GammaPro Angled Standard ProbeKubtecIZD2025-03-26
00841911102526neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102533neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102540neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102557neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-07-31
04260152884415Navigator 3 Wired Probe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884422Navigator 3 Wired Probe Cablecrystal-photonics GmbHIZD2024-03-19
04260152884484Navigator 3 Wired Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884491Navigator 3 WirelessPprobe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884507Navigator 3 Wireless Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884514Navigator 3 Wireless Probe Battery Packcrystal-photonics GmbHIZD2024-03-19
04260152887102Navigator 3 Control Unitcrystal-photonics GmbHIZD2024-03-19
00860008268907Node Seeker 2000INTRA MEDICAL IMAGING LLCIZD2023-05-03
08437018413294GAMMAPROGENERAL EQUIPMENT FOR MEDICAL IMAGING SAIZD2023-01-18
B939CW5APO1050CareWiseSOUTHERN SCIENTIFIC LIMITEDIZD2023-01-16
B939CW5APO1060CareWiseSOUTHERN SCIENTIFIC LIMITEDIZD2023-01-16
00850014578008Lara ReaderLUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578015Lara Sensor, Type 1LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578022Lara Sensor, Type 2LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578039Lara Sensor, Type 3LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578046Lara Sensor, Type 4LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578053Lara Sensor, Type 5LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578060Lara Sensor, Type 6LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578077Lara Sensor, Type 7LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578084Lara Sensor, Type 8LUCERNO DYNAMICS, LLCIZD2023-01-01