Senti Desktop Flex

GUDID 04260223145285

Senti Desktop Flex Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 4 Advanced AN100653 7. Power supply AN100524 + AN100525-USA 8. USB data cable AN100418

PATH medical GmbH

Pure-tone audiometer
Primary Device ID04260223145285
NIH Device Record Keyc9c57c57-9579-463d-9362-c6015f669544
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenti Desktop Flex
Version Model Number100470-SC
Company DUNS551540334
Company NamePATH medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS104260223145285 [Primary]

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-06
Device Publish Date2020-06-27

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