Ingenuity Flex

GUDID 00884838059528

Philips Medical Systems (cleveland), Inc.

Full-body CT system
Primary Device ID00884838059528
NIH Device Record Key5ed43704-31a5-4ef6-b58b-5bdbacc1e7cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameIngenuity Flex
Version Model Number728317
Company DUNS001224989
Company NamePhilips Medical Systems (cleveland), 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 Datefalse
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
GS100884838059528 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-15
Device Publish Date2016-09-23

Devices Manufactured by Philips Medical Systems (cleveland), Inc.

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00884838059528 - Ingenuity Flex2019-07-15
00884838059528 - Ingenuity Flex2019-07-15
00884838059443 - Ingenuity TF2018-07-06

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