TED Applicator AATE17112102

GUDID 07290110123611

TED Applicator

ALMA LASERS LTD.

Physical therapy ultrasound system applicator
Primary Device ID07290110123611
NIH Device Record Keyb25209ab-e38e-40ff-9064-a2aef9cf7226
Commercial Distribution StatusIn Commercial Distribution
Brand NameTED Applicator
Version Model Number1
Catalog NumberAATE17112102
Company DUNS532283264
Company NameALMA LASERS LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110123611 [Primary]

FDA Product Code

ISAMassager, Therapeutic, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-23
Device Publish Date2024-09-15

Devices Manufactured by ALMA LASERS LTD.

07290110123567 - Alma TED System 120V 50/60HZ2024-09-23 Alma TED System 120V 50/60HZ
07290110123611 - TED Applicator2024-09-23TED Applicator
07290110123611 - TED Applicator2024-09-23 TED Applicator
17290110123526 - Diode 755nm Alex Applicator for Soprano Titanium (Black)2024-03-25 Diode 755nm Alex Applicator for Soprano Titanium (Black)
07290110123451 - ClearVas2024-02-26
07290110123468 - ClearLift2024-02-26
07290110123475 - Alma SupErb2024-02-26
07290110123482 - ClearSkin2024-02-26
07290110123444 - NIR Face (6) HP2024-02-07

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