FDA.reportPublic FDA data

Alpha 2 MPO ePlus

Primary DI
00643169862210
Brand
Alpha 2 MPO ePlus
Company
MEDTRONIC XOMED, INC.
Model
S0821-00
Device description
PROCESSOR S0821-00 ALPHA2MPOR BROWN
Published
2017-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBXPELVIMETER, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBXPelvimeter, InternalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153391000Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc.2016-06-16LXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169862210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169862210006431698622106431698622100643169862210

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn bone-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically consists of a microphone, amplifier, and vibrator, mounted or magnetically connected on a headband or the arm(s) of spectacles, or magnetically connected to an implantable magnet. The microphone receives sound waves and converts them into electrical signals sent to the vibrator which transmits vibrations, typically through the mastoid bone, to the inner ears for hearing. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
00643169644786Otomag™ Attract™ Magnetic SpacerS0266-212016-04-15
00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15
00643169644830Otomag™ Attract™ Magnetic SpacerS0542-042016-04-15
00643169644847Otomag™ Attract™ Magnetic SpacerS0542-052016-04-15
00643169644854Otomag™ Attract™ Magnetic SpacerS0542-062016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169862227Alpha 2 MPO ePlusMEDTRONIC XOMED, INC.LBX2017-10-02
00643169862234Alpha 2 MPO ePlusMEDTRONIC XOMED, INC.LBX2017-10-02
00643169862241Alpha 2 MPO ePlusMEDTRONIC XOMED, INC.LBX2017-10-02
00643169868854Sophono™MEDTRONIC XOMED, INC.LBX2017-10-02
00643169930780NAMEDTRONIC XOMED, INC.LBX2017-10-02