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

EPRC0220001A2 - ACRY PRINT RU-001 Temporary	2025-04-08 ACRY PRINT RU-001 Temporary 1000g A2
EPRC0220001A3 - ACRY PRINT RU-001 Temporary	2025-04-08 ACRY PRINT RU-001 Temporary 1000g A3
EPRC0220003 - ACRY PRINT RU-003 Try-In	2025-04-08 ACRY PRINT RU-003 Try-In 1000g A2
EPRC0220004 - ACRY PRINT RU-004 Denture HI	2025-04-08 ACRY PRINT RU-004 Denture HI 1000g Orange-Pink
EPRC0220005 - ACRY PRINT RU-005 Guide	2025-04-08 ACRY PRINT RU-005 Guide 1000g Clear-Transparent
EPRC768345 - UCAN Print Base	2025-04-08 UCAN Print Base 1000g color 33
EPRC768485 - UCAN Print Try-In	2025-04-08 UCAN Print Try-In 1000g A2
EPRC768486 - UCAN Print Splint	2025-04-08 UCAN Print Splint 1000g Transparent