AccessGUDID - DEVICE: Node Seeker 2000 (00860008268907)

GUDID

Device Identifier (DI) Information

Brand Name: Node Seeker 2000
Version or Model: NS2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTRA MEDICAL IMAGING LLC

Primary DI Number: 00860008268907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025174488 *Terms of Use

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.

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:	No
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?
65055	Intraoperative gamma radiation detection system probe, reusable	An 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.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f2ddde4c-a619-411f-9ce5-e5c00e3fc311
Public Version Date: May 11, 2023
Public Version Number: 1
DI Record Publish Date: May 03, 2023