AccessGUDID - DEVICE: GammaPod™ Imager Loader and Couch (00850002615036)

GUDID

Device Identifier (DI) Information

Brand Name: GammaPod™ Imager Loader and Couch
Version or Model: Model B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XMSGP030A08.00-0.00
Company Name: XCISION MEDICAL SYSTEMS, LLC

Primary DI Number: 00850002615036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788286941 *Terms of Use

Device Description: Imager Loader and Couch

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40680	Multi-purpose diagnostic imaging table	An electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWB	System, Radiation Therapy, Radionuclide

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 373dd31d-f262-4d84-bc27-6428e6ea6f93
Public Version Date: September 01, 2025
Public Version Number: 3
DI Record Publish Date: March 01, 2019