AccessGUDID - DEVICE: TruNode Surgical Gamma Probe (15420045512856)

GUDID

Device Identifier (DI) Information

Brand Name: TruNode Surgical Gamma Probe
Version or Model: 120-807605
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 120-807605
Company Name: Hologic, Inc.

Primary DI Number: 15420045512856
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: A sterile, wireless, battery operated probe used to detect and quantify gamma rays from Tc-99m and I-125 isotopes, communicated to the User Feedback Unit.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZD	Probe, uptake, nuclear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 37 Degrees Celsius
Storage Environment Temperature: between -15 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ccddfaec-dc9a-480f-96c5-878e7981de4a
Public Version Date: April 19, 2024
Public Version Number: 3
DI Record Publish Date: April 02, 2020