audioprint INR-1 A1000275

GUDID EPRCA1000275

audioprint INR-1 Generative resin for production of earpieces

pro3dure medical GmbH

Earmould, custom-made

Primary Device ID	EPRCA1000275
NIH Device Record Key	c517701d-920f-4fe7-bacb-892042e5bd34
Commercial Distribution Status	In Commercial Distribution
Brand Name	audioprint INR-1
Version Model Number	500 g bottle ; smoke-grey
Catalog Number	A1000275
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	true
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 Identifiers

Device Issuing Agency	Device ID
HIBCC	EPRCA1000275 [Primary]

FDA Product Code

ESD	Hearing Aid, Air Conduction

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-09-20
Device Publish Date	2022-09-12

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