audioprint HPR-1 A1001604

GUDID EPRCA1001604

audioprint HPR-1

pro3dure medical GmbH

Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made
Primary Device IDEPRCA1001604
NIH Device Record Keyf9345fe1-2da8-45cc-b9bc-14642ff38a7d
Commercial Distribution StatusIn Commercial Distribution
Brand Nameaudioprint HPR-1
Version Model Number1000 g bottle, Neon Yellow
Catalog NumberA1001604
Company DUNS312947842
Company Namepro3dure medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEPRCA1001604 [Primary]

FDA Product Code

ESDHearing Aid, Air-Conduction, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [audioprint HPR-1]

EPRCA1001606audioprint HPR-1
EPRCA1001605audioprint HPR-1
EPRCA1001604audioprint HPR-1
EPRCA1001603audioprint HPR-1
EPRCA1001602audioprint HPR-1
EPRCA1001601audioprint HPR-1
EPRCA1001600audioprint HPR-1

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