AccessGUDID - DEVICE: D-SPECT® (07290108670011)

GUDID

Device Identifier (DI) Information

Brand Name: D-SPECT®
Version or Model: 004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8010029-01
Company Name: SPECTRUM DYNAMICS MEDICAL, INC

Primary DI Number: 07290108670011
Issuing Agency: GS1
Commercial Distribution End Date: December 11, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 078864620 *Terms of Use

Device Description: Single-photon emission computed tomography 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):	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?
40643	SPECT system, annular detector array	An assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system designed exclusively for use in tomographic imaging applications. It detects, records, quantifies and analyses radionuclide emissions produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. The gantry position is fixed and the imaging table/chair moves/rotates under computer or manual control. Its imaging capabilities include static and dynamic imaging applications and three-dimensional (3-D) digital image reconstruction/display at any angle including axial, coronal and sagittal planes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission
LLZ	System, Image Processing, Radiological

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: 77e8191c-327b-4256-8718-3aaea7d8e895
Public Version Date: December 12, 2022
Public Version Number: 4
DI Record Publish Date: September 22, 2016