FDA.reportPublic FDA data

Unitron

Primary DI
00698764424127
Brand
Unitron
Company
Unitron Hearing Ltd
Model
076-5016-M520
Catalog number
076-5016-M520
Device description
uDirect 2 w/ Univ. Power Supply
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00698764424127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00698764424127006987644241276987644241270698764424127

GMDN Terms#

Term, Definition table
TermDefinition
Spermatozoa/semen analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 519 895 0100Quality@unitron.com

Regulatory Flags#

DUNS number
201252087
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00698764593694Unitron076-5037-T820076-5037-T8202016-09-12
00698764424769Unitron076-5014-00001076-5014-000012016-09-12
00698764479707Unitron050-5600-P6050-5600-P62016-09-12
07630034300000Unitron050-5695-P7050-5695-P72016-09-12
07630034300017Unitron050-5695-P6050-5695-P62016-09-12
07630034300024Unitron050-5694-S7050-5694-S72016-09-12
07630034300031Unitron050-5694-S6050-5694-S62016-09-12
07630034300048Unitron050-5694-S5050-5694-S52016-09-12
07630034300055Unitron050-5694-S3050-5694-S32016-09-12
07630034300062Unitron050-5694-S2050-5694-S22016-09-12
07630034300079Unitron050-5694-Q9050-5694-Q92016-09-12
07630034300086Unitron050-5694-P8050-5694-P82016-09-12
07630034300093Unitron050-5694-P7050-5694-P72016-09-12
07630034300109Unitron050-5694-P6050-5694-P62016-09-12
07630034300116Unitron050-5694-P4050-5694-P42016-09-12
07630034300123Unitron050-5694-P2050-5694-P22016-09-12
07630034300130Unitron050-5694-01050-5694-012016-09-12
07630034300147Unitron050-5693-S7050-5693-S72016-09-12
07630034300154Unitron050-5693-S6050-5693-S62016-09-12
07630034300161Unitron050-5693-S5050-5693-S52016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880279566SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880279573SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293470SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293487SigniaWs Audiology Usa, Inc.OSM2026-05-27
07613275596814PhonakSonova AGOSM2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601402PhonakSonova AGOSM2018-02-28
07613275601426PhonakSonova AGOSM2018-02-28
07613275601501PhonakSonova AGOSM2018-02-28
07613275601518PhonakSonova AGOSM2018-02-28
07613275601556PhonakSonova AGOSM2018-02-28
07613275601594PhonakSonova AGOSM2018-02-28
07613275601600PhonakSonova AGOSM2018-02-28
07613275601655PhonakSonova AGOSM2018-02-28
07613275601662PhonakSonova AGOSM2018-02-28
07613275601686PhonakSonova AGOSM2018-02-28
07613275601693PhonakSonova AGOSM2018-02-28
07613275602935PhonakSonova AGOSM2018-02-28
07613275602959PhonakSonova AGOSM2018-02-28