FDA.reportPublic FDA data

Node Seeker 2000

Primary DI
00860008268907
Brand
Node Seeker 2000
Company
INTRA MEDICAL IMAGING LLC
Model
NS2000
Device description
Radionuclide uptake probes are used after the patient is injected with a specific radiotracer, or a seed of radioactivity is placed inside the patient’s body.
Published
2023-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00860008268907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008268907008600082689078600082689070860008268907

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative gamma radiation detection system probe, reusableAn electrically-powered, invasive component of an intraoperative gamma radiation detection system intended to be introduced into the body during a surgical procedure to detect and quantify gamma radiation emitted from previously-administered radiopharmaceuticals (e.g., localized in sentinel lymph nodes), in conjunction with a dedicated control unit (not included). It is typically manipulated using surgical forceps and incorporates a crystal scintillator and photomultiplier. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
025174488
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
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
00850014578091Lara QC FixtureLUCERNO DYNAMICS, LLCIZD2023-01-01