audioprint GR-11.1 A1001511

GUDID EPRCA1001511

Earmould, custom-made

Primary Device ID	EPRCA1001511
NIH Device Record Key	e8eb8e9b-8b91-4465-93f4-4ed8db650c27
Commercial Distribution Status	In Commercial Distribution
Brand Name	audioprint GR-11.1
Version Model Number	1kg - black
Catalog Number	A1001511
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

Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight

Device Issuing Agency	Device ID
HIBCC	EPRCA1001511 [Primary]

ESD	Hearing Aid, Air Conduction

Steralize Prior To Use	false
Device Is Sterile	false

EPRCA1001516	audioprint GR-11.1 1 kg ; white
EPRCA1001515	audioprint GR-11.1 1 kg ; red
EPRCA1001514	audioprint GR-11.1 1 kg ; blue
EPRCA1001513	audioprint GR-11.1 1 kg ; beige
EPRCA1001512	audioprint GR-11.1 1 kg ; light-brown
EPRCA1001511	audioprint GR-11.1 1 kg ; black
EPRCA1001510	audioprint GR-11.1 1 kg ; clear transparent