AccessGUDID - DEVICE: BodyMD (05711665003019)

GUDID

Device Identifier (DI) Information

Brand Name: BodyMD
Version or Model: QuantumCam Gamma Camera System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9PMS3131
Company Name: Ddd-Diagnostic A/S

Primary DI Number: 05711665003019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305116642 *Terms of Use

Device Description: Gamma Camera System

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):	No
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?
40640	Stationary gamma camera system	An assembly of static diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, crystal(s), a collimator and a set of photomultiplier tubes or photo diodes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140206	000

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
Width: 291 Centimeter
Depth: 197 Centimeter
Height: 225 Centimeter
Weight: 2144 Kilogram

Device Record Status

Public Device Record Key: 44abf502-269c-43a1-b90c-e0aedb2e283f
Public Version Date: August 06, 2018
Public Version Number: 1
DI Record Publish Date: July 04, 2018