Analogic ImpaCT

GUDID 00814277020308

Analogic ImpaCT 128-slice

ANALOGIC CORPORATION

Full-body CT system
Primary Device ID00814277020308
NIH Device Record Keyd306f36c-3d1e-4d6e-9517-fa87441b00d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnalogic ImpaCT
Version Model Number10-79245-01
Company DUNS019677418
Company NameANALOGIC CORPORATION
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
GS100814277020308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-15

On-Brand Devices [Analogic ImpaCT]

00814277020308Analogic ImpaCT 128-slice
00814277020162Analogic ImpaCT 64-slice
00814277020155Analogic ImpaCT 16-slice

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