GUDID 00643169719811

SOFTBAND S0264-22 WHITE BINAURAL

MEDTRONIC XOMED, INC.

Head-worn bone-conduction hearing aid Head-worn bone-conduction hearing aid Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn
Primary Device ID00643169719811
NIH Device Record Keya152de3a-19d2-4d27-bd5b-9bbbdf52d69e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS0264-22
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169719811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXBHearing aid, bone conduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-02

Devices Manufactured by MEDTRONIC XOMED, INC.

00763000033385 - HA/C Polycel® Brackmann Total2024-05-20 PROSTHESIS 1112303 BRACKMANN H/AC TOTAL
00763000034832 - Sheehy HA/C Polycel® P.O.P.2024-05-20 PROSTHESIS 1112362 SHEEHY POP H/A POLYCL
00763000034849 - Sheehy HA/C Polycel® T.O.P.2024-05-20 PROSTHESIS 1112363 SHEEHY TOP H/A POLYCL
00763000036591 - Big Easy® Piston2024-05-20 PROSTHESIS 1156611 PLAT/TI .5X4.5MM LFT
00763000036607 - Big Easy® Piston2024-05-20 PROSTHESIS 1156612 PLAT/TI .5X4.75MM LFT
00763000036614 - Big Easy® Piston2024-05-20 PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT
00763000036621 - Big Easy® Piston2024-05-20 PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT
00763000036638 - Big Easy® Piston2024-05-20 PROSTHESIS 1156622 PLAT/TI .5X4.75M RT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.