FDA.reportPublic FDA data

Unitron

Primary DI
00698764593694
Brand
Unitron
Company
Unitron Hearing Ltd
Model
076-5037-T820
Catalog number
076-5037-T820
Device description
uStream incl. US/EU 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
00698764593694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00698764593694006987645936946987645936940698764593694

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
00698764424127Unitron076-5016-M520076-5016-M5202016-09-12
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
07613389927696Phonak CROS E-RSonova AGOSM2026-08-03
07613389927719Phonak CROS E-RSonova AGOSM2026-08-03
07613389927726Phonak CROS E-RSonova AGOSM2026-08-03
07613389927733Phonak CROS E-RSonova AGOSM2026-08-03
07613389927740Phonak CROS E-RSonova AGOSM2026-08-03
07613389927757Phonak CROS E-RSonova AGOSM2026-08-03
07613389927764Phonak CROS E-RSonova AGOSM2026-08-03
07613389927771Phonak CROS E-RSonova AGOSM2026-08-03
07613389928181Phonak CROS E-RSonova AGOSM2026-08-03
05714878800291MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26