Replexa+ Device

GUDID 00850886008009

Short-wave diathermy treatment system, home-use

Primary Device ID	00850886008009
NIH Device Record Key	5ad6fd6d-4b2f-44c1-be4a-8b9e6409dda5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Replexa+ Device
Version Model Number	C1416
Company DUNS	604679527
Company Name	PROMEDTEK, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850886008009 [Primary]

IMJ	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Steralize Prior To Use	false
Device Is Sterile	false

00850886008009 - Replexa+ Device	2019-07-16Replexa+ Model C1416 Shortwave Diathermy Device
00850886008009 - Replexa+ Device	2019-07-16 Replexa+ Model C1416 Shortwave Diathermy Device
00850886008016 - Replexa+ Treatment Applicator	2019-07-16 Replexa+ Model C1416 Shortwave Diathermy Treatment Applicator