Profile Applicator

GUDID 00812265010294

Dermatological extracorporeal shock wave therapy system applicator

Primary Device ID	00812265010294
NIH Device Record Key	c0d43bcc-b3cd-43fc-be1c-3db053d60cb8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Profile Applicator
Version Model Number	FLE0103
Company DUNS	832217439
Company Name	Sanuwave, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00812265010294 [Primary]

ISA	Massager, Therapeutic, Electric

Steralize Prior To Use	false
Device Is Sterile	false

00812265010300	Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
00812265010294	Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)