GUDID 00681490909907

PROSTHESIS 1150001 UNIV TITAN CAM HEAD

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total
Primary Device ID00681490909907
NIH Device Record Key8e5921b0-69d1-4005-9e31-333c62ca8e3a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1150001
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490909907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETBPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-09

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

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