FDA.reportPublic FDA data

Navigator Superficial Head & Neck Probe, 11mm Wired

Primary DI
00810049840044
Brand
Navigator Superficial Head & Neck Probe, 11mm Wired
Company
Dilon Technologies, Inc.
Model
SP-2S11-53
Catalog number
SP-2S11-53
Published
2022-12-08
Public version status
Update
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
00810049840044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810049840044008100498400448100498400440810049840044

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061727272
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810049840010CoPilot VL Disposable Sheaths Size 1, Box of 10371037102022-12-08
10810049840027CoPilot VL Disposable Sheaths, Size 2 Case of 10372037202022-12-08
10810049840034CoPilot VL Disposable Sheaths, Size 3373037302022-12-08
00810049840006Navigator 2.0 Control Unit2.0N2-9800-002022-12-08
00810049840020Navigator Laparoscopic Probe, 10mm Wired SP-2S10-31SP-2S10-312022-12-08
00810049840037Navigator Daniel Lung Probe, 10mm Wired SP-2S10-31DSP-2S10-31D2022-12-08
00810049840051Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, AngledSP-2A14-67SP-2A14-672022-12-08
00810049840068Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, StraightSP-2S14-67SP-2S14-672022-12-08
00810049840075Navigator Wireless Probe, 14mm AngledWP-9000-14WP-9000-142022-12-08
00810049840082Navigator Wireless Probe, 14mm StraightWP-9000-14SWP-9000-14S2022-12-08
01810049840012CoPilot VL Disposable Sheaths Size 1, Box of 10371037102022-12-08
01810049840029CoPilot VL Disposable Sheaths, Size 2 Case of 10372037202022-12-08
01810049840036CoPilot VL Disposable Sheaths, Size 3373037302022-12-08
00810049840099CoPilot VL Disposable Sheaths, Size 1361036102022-12-07
00810049840105CoPilot VL Disposable Sheaths, Size 2362036202022-12-07
00810049840112CoPilot VL Disposable Sheaths, Size 3363036302022-12-07
00810049840129CoPilot VL Disposable Sheaths, Slim, Size 43640-S3640-S2022-12-07
00810049840136CoPilot VL Disposable Sheaths, Size 5365036502022-12-07
00810049840143CoPilot VL Disposable Sheaths, Slim, Size 33650-S3650-S2022-12-07
00810049840150CoPilot VL Disposable Sheaths, Slim, Size 33630-S3630-S2022-12-07

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