L38xi/10-5 MHz Armored P19626

GUDID 00841517105648

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517105648
NIH Device Record Key11d1602b-a106-4734-9f7e-e1c74dc2ad67
Commercial Distribution StatusIn Commercial Distribution
Brand NameL38xi/10-5 MHz Armored
Version Model NumberP19626-10A
Catalog NumberP19626
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517105648 [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 Date2020-06-30
Device Publish Date2020-06-22

On-Brand Devices [L38xi/10-5 MHz Armored]

00841517100452Diagnostic Ultrasound Transducer
00841517105648P19626-10A
00841517107185Diagnostic Ultrasound Transducer
00841517107628P19626-20A
00841517109004Diagnostic Ultrasound Transducer
00841517110437Diagnostic Ultrasound Transducer

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