Sophono™

Contact Domains#

Code, Name table
Code	Name
LBX	PELVIMETER, INTERNAL

Code, Device, Specialty table
Code	Device	Specialty	Class
LBX	Pelvimeter, Internal	Obstetrics/Gynecology	2

Submission, Supplement table
Submission	Supplement
K153391	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K153391	000	Sophono Bone Conduction Systems (S) Configuration and (M) Configuration	Sophono, Inc.	2016-06-16	LXB

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00643169868854	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00643169868854	00643169868854	643169868854	0643169868854

Term, Definition table
Term	Definition
Head-worn bone-conduction hearing aid implantable magnet	A 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.

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	-20 Degrees Celsius	50 Degrees Celsius

Method table
Method

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

Primary DI, Brand, Model table
Primary DI	Brand	Model	Published
20763000089652	SLIDE-ON® ENDOSHEATH®	224501	2018-07-07
00681490038997	N/A	1356501	2017-09-10
00681490040488	NA	1416000	2015-06-23
00681490040518	NA	1416030	2015-06-23
20681490040604	N/A	1419020	2017-10-13
20681490041762	NA	1514000	2016-04-30
20681490042424	NA	1532500	2015-06-25
20681490069315	NA	3118530	2016-04-17
20681490138622	BRIDGEMASTER®	600302	2017-09-09
20681490138646	BOOMERANG®	600500	2017-09-09
20643169232000	Alar ™	15000	2017-10-13
00643169553019	XPS®	1898200TLO	2016-05-01
00643169564749	VISAO®	3334800LO	2016-05-01
20613994394525	SLIDE-ON®	444401	2016-04-23
20613994394747	SLIDE-ON®	332401	2016-04-23
20613994394754	SLIDE-ON®	334301	2016-04-29
20613994657798	SLIDE-ON®	035102	2016-04-29
20613994657811	SLIDE-ON®	335601	2016-04-29
20613994657828	SLIDE-ON®	445601	2016-05-13
00763000032746	Neuray®	8004005	2019-03-17

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00643169862210	Alpha 2 MPO ePlus	MEDTRONIC XOMED, INC.	LBX	2017-10-02
00643169862227	Alpha 2 MPO ePlus	MEDTRONIC XOMED, INC.	LBX	2017-10-02
00643169862234	Alpha 2 MPO ePlus	MEDTRONIC XOMED, INC.	LBX	2017-10-02
00643169862241	Alpha 2 MPO ePlus	MEDTRONIC XOMED, INC.	LBX	2017-10-02
00643169930780	NA	MEDTRONIC XOMED, INC.	LBX	2017-10-02