otosil SL-1 I MSI A0034160

GUDID EPRCA0034160

Earmould, custom-made

Primary Device ID	EPRCA0034160
NIH Device Record Key	1f289d8c-6c24-4e0d-906d-a14385e63a2b
Commercial Distribution Status	In Commercial Distribution
Brand Name	otosil SL-1 I MSI
Version Model Number	250 g - Clear Transparent
Catalog Number	A0034160
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	EPRCA0034160 [Primary]

ESD	Hearing Aid, Air Conduction

Steralize Prior To Use	false
Device Is Sterile	false

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EPRCA0034150 - otosil SL-1	2023-10-26 otosil SL-1 250 g; clear transparent
EPRCA0034151 - otosil SL-1	2023-10-26 otosil SL-1 100 g; clear transparent
EPRCA0034160 - otosil SL-1 I MSI	2023-10-26otosil SL-1 I MSI 250 g; clear transparent
EPRCA0034160 - otosil SL-1 I MSI	2023-10-26 otosil SL-1 I MSI 250 g; clear transparent