PRO3DURE SysTherm PU A4020145

GUDID EPRCA4020145

Earmould, custom-made

Primary Device ID	EPRCA4020145
NIH Device Record Key	fd1b3430-d5f1-466d-b1f6-d38c3a4a0ff1
Commercial Distribution Status	In Commercial Distribution
Brand Name	PRO3DURE SysTherm PU
Version Model Number	SysTherm PU Red
Catalog Number	A4020145
Company DUNS	312947842
Company Name	pro3dure medical GmbH
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	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
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
HIBCC	EPRCA4020145 [Primary]

ESD	Hearing Aid, Air Conduction

Steralize Prior To Use	false
Device Is Sterile	false

EPRCA4020124	SysTherm PU clear-transparent standard packaging 2x50g
EPRCA4020144	SysTherm PU pink-transparent standard packaging 2x50g
EPRCA4020143	SysTherm PU Reddish-Transparent standard packaging 2x50g
EPRCA4020147	SysTherm PU Black standard packaging 2x50g
EPRCA4020146	SysTherm PU Blue standard packaging 2x50g
EPRCA4020145	SysTherm PU Red standard packaging 2x50g