FDA.report

PRO3DURE GR-1guide

Primary DI
EPRCD1000300
Brand
PRO3DURE GR-1guide
Company
pro3dure medical GmbH
Model
1kg - clear-transparent
Device description
printodent GR-1 guide
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DYTMaintainer, Space Preformed, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EPRCD1000300PrimaryHIBCC0

GMDN Terms

TermDefinition
Earmould, custom-madeA custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+4923749200500info@pro3dure.com

Regulatory Flags

DUNS number
312947842
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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EPRCA0010200otosil IS-28 double cartridges of 2 x 25 mlA00102002023-10-18
EPRCA0011000otosil PS-12 x 300g ; Orange - WhiteA00110002023-10-18
EPRCA0034150otosil SL-1250 g - Clear Transparent A00341502023-10-18
EPRCA0034151otosil SL-1100 g - Clear Transparent A00341512023-10-18
EPRCA0034160otosil SL-1 I MSI250 g - Clear Transparent A00341602023-10-18
EPRCA0034300otosil protect 50 I MSI neon-yellowA00343002023-10-18

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