D750b

GUDID 00840682138741

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system
Primary Device ID00840682138741
NIH Device Record Key21d9b32f-def1-44e1-b6ce-0b58a1ee09ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameD750b
Version Model NumberBiopsy
Company DUNS532102365
Company NameG E MEDICAL SYSTEMS ISRAEL LTD.
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
GS100840682138741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYXCamera, scintillation (gamma)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-02

On-Brand Devices [D750b]

00840682138758Gantry UPG
00840682138741Biopsy
00840682138697Gantry

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