Kosmos Torso - Refurbished

GUDID 09353278000441

ECHONOUS, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID09353278000441
NIH Device Record Key4a84a132-be59-4014-a0e3-3a7f3ce34b62
Commercial Distribution StatusIn Commercial Distribution
Brand NameKosmos Torso - Refurbished
Version Model NumberR006025
Company DUNS080481089
Company NameECHONOUS, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS109353278000441 [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 Date2020-12-21
Device Publish Date2020-12-11

Devices Manufactured by ECHONOUS, INC.

09353278000830 - Kosmos2025-08-18 MENDAERA 210-00161: PACKAGED TORSO-ONE USB PROBE
09353278000847 - Kosmos2025-08-18 MENDAERA 210-00160: PACKAGED LINEAR LEXSA PROBE
09353278000823 - Kosmos OTS iOS 2025-03-03 Kosmos Application loaded on an iPad.
09353278000854 - Kosmos Link2025-03-03 Kosmos Link
09353278000762 - Kosmos OTS iOS 2024-05-14 KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
09353278000632 - Kosmos Power Pack2023-03-20 Kosmos Power Pack
09353278000724 - Kosmos Power Pack (Refurbished)2023-03-20 Kosmos Power Pack (Refurbished)
09353278000663 - EchoNous Samsung S8 Tablet with Software2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software

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