FDA.reportPublic FDA data

NA

Primary DI
00643169719958
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
S0585-00
Device description
SURGICAL TEMPLATE S0585-00 NON STERILE
Published
2017-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXBHearing aid, bone conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

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
00643169719958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169719958006431697199586431697199580643169719958

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.

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000089652SLIDE-ON® ENDOSHEATH®2245012018-07-07
00681490038997N/A13565012017-09-10
00681490040488NA14160002015-06-23
00681490040518NA14160302015-06-23
20681490040604N/A14190202017-10-13
20681490041762NA15140002016-04-30
20681490042424NA15325002015-06-25
20681490069315NA31185302016-04-17
20681490138622BRIDGEMASTER®6003022017-09-09
20681490138646BOOMERANG®6005002017-09-09
20643169232000Alar ™150002017-10-13
00643169553019XPS®1898200TLO2016-05-01
00643169564749VISAO®3334800LO2016-05-01
20613994394525SLIDE-ON®4444012016-04-23
20613994394747SLIDE-ON®3324012016-04-23
20613994394754SLIDE-ON®3343012016-04-29
20613994657798SLIDE-ON®0351022016-04-29
20613994657811SLIDE-ON®3356012016-04-29
20613994657828SLIDE-ON®4456012016-05-13
00763000032746Neuray®80040052019-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712149027743Ponto InstantOticon Medical ABLXB2026-05-21
09120041056673contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056697contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056703contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056710contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056727contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056734contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056741contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056758contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056765contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056772contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056895HearbowBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041050145contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050176contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050190contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050220contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051852contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051906contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052149contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052156contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052163contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052309contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052316contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052323contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059575contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059582contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059599contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059605contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059612contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059650contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17