FDA.reportPublic FDA data

NA

Primary DI
00643169930780
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
S0699
Device description
FITTING KIT S0699 IMPLANT
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
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
00643169930780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169930780006431699307806431699307800643169930780

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device configuration kitA collection of reusable components of a hearing device intended to be used by an audiologist to configure the hearing device for an individual patient; it typically includes software, a cable, and scale retention. The devices are retained by the audiologist and not provided to a patient. This is a reusable device.

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
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
00643169868854Sophono™MEDTRONIC XOMED, INC.LBX2017-10-02