C5-2

GUDID 00884838068148

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00884838068148
NIH Device Record Key0c17c9e3-33f0-4e10-802c-83a7311c0eba
Commercial Distribution StatusIn Commercial Distribution
Brand NameC5-2
Version Model Number989605454411
Company DUNS063377717
Company NamePhilips Ultrasound, Inc.
Device Count1
DM Exempttrue
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
GS100884838068148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-11-12
Device Publish Date2018-05-23

On-Brand Devices [C5-2]

00884838086555989605477131
00884838068148989605454411

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.