Sophono™

Primary DI
00643169868854
Brand
Sophono™
Company
MEDTRONIC XOMED, INC.
Model
S1000-00
Device description
MAGNETIC IMPLANT S1000-00
Published
2017-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
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
00643169868854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169868854006431698688546431698688540643169868854

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn bone-conduction hearing aid implantable magnetA sterile implantable magnetized device intended to be used to magnetically hold in place a head-worn bone-conduction hearing aid (against the skin on the side of the head), usually using a base plate. It is metallic, typically flat-disc- or dual-disc-shaped, and permanently implanted with screws in the mastoid process or parietal bone of the skull. Disposable devices associated with implantation may be included.

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00199150064083ApexCut187BL40122026-04-25
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00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169862210Alpha 2 MPO ePlusMEDTRONIC XOMED, INC.LBX2017-10-02
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
00643169930780NAMEDTRONIC XOMED, INC.LBX2017-10-02