otosil SL-1 A0034150

GUDID EPRCA0034150

Earmould, custom-made

Primary Device ID	EPRCA0034150
NIH Device Record Key	9dfb335d-94ec-4fe8-8d8e-f4328c50eb3e
Commercial Distribution Status	In Commercial Distribution
Brand Name	otosil SL-1
Version Model Number	250 g - Clear Transparent
Catalog Number	A0034150
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	EPRCA0034150 [Primary]

ESD	Hearing Aid, Air Conduction

Steralize Prior To Use	false
Device Is Sterile	false

EPRCA0034151	otosil SL-1 100 g; clear transparent
EPRCA0034150	otosil SL-1 250 g; clear transparent