L25x/13-6 MHz P07691

GUDID 00841517105006

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517105006
NIH Device Record Key07dbaa06-c4bc-484f-8553-6d00485e6617
Commercial Distribution StatusIn Commercial Distribution
Brand NameL25x/13-6 MHz
Version Model NumberP07691-80A
Catalog NumberP07691
Company DUNS014438860
Company NameFUJIFILM SONOSITE, 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

Customer Support Contacts

Phone+1(999)999-9999
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *N/A

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517105006 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-02
Device Publish Date2019-08-23

On-Brand Devices [L25x/13-6 MHz]

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00841517104856Diagnostic Ultrasound Transducer
00841517102906Diagnostic Ultrasound Transducer
00841517102258Diagnostic Ultrasound Transducer
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00841517100445Diagnostic Ultrasound Transducer
00841517100438Diagnostic Ultrasound Transducer
00841517106942Diagnostic Ultrasound Transducer
00841517107581P22950-20A
00841517107932Diagnostic Ultrasound Transducer
00841517109110Diagnostic Ultrasound Transducer
00841517108946Diagnostic Ultrasound Transducer
00841517110451Diagnostic Ultrasound Transducer
00841517110499Diagnostic Ultrasound Transducer

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