TruNode Surgical Gamma Probe

Basic Information

• Brand Name: TruNode Surgical Gamma Probe
• Primary DI: 15420045512856
• Version / Model: 120-807605
• Catalog Number: 120-807605
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-02
• Public Version: 2
• Public Version Date: 2020-10-29
• Public Version Status: Update
• Public Device Record Key: ccddfaec-dc9a-480f-96c5-878e7981de4a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZD	Probe, uptake, nuclear	Radiology	892.1320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40646	Hand-held-detector nuclear medicine system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045512856	GS1