D-SPECT Refurbished 8010013-01

GUDID 07290108670158

Single Photon Emission Computed Tomography system

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system, annular detector array
Primary Device ID07290108670158
NIH Device Record Key2198db02-7b95-4fe6-8ab4-72c7ffd1356c
Commercial Distribution StatusIn Commercial Distribution
Brand NameD-SPECT Refurbished
Version Model NumberD-SPECT 004
Catalog Number8010013-01
Company DUNS078864620
Company NameSPECTRUM DYNAMICS MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290108670158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-12-21
Device Publish Date2020-08-26

On-Brand Devices [D-SPECT Refurbished]

00729018670158Single Photon Emission Computed Tomography system
07290108670158Single Photon Emission Computed Tomography system

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