GUDID 20681490176723

PROBE 8225110 10PK PRASS MONO STD ROHS

MEDTRONIC XOMED, INC.

Electromyographic needle electrode, single-use
Primary Device ID20681490176723
NIH Device Record Key5b1c8352-21f2-40e6-b446-62892ff3e1a9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8225110
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490176729 [Primary]
GS120681490176723 [Package]
Contains: 00681490176729
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNSTIMULATOR, NERVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-04-17

Devices Manufactured by MEDTRONIC XOMED, INC.

00763000891862 - ENT NIM Electrode2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS
00763000891879 - ENT NIM Electrode2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS
00763000580483 - ENT NIM Vital2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS
00763000578022 - N/A2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL
00763000578039 - N/A2024-09-24 SPLINT 1528111 5PK EXTERNAL NASAL SMALL
00763000578046 - N/A2024-09-24 SPLINT 1528120 25PK EXTERNAL NASAL MED
00763000578053 - N/A2024-09-24 SPLINT 1528121 5PK EXTERNAL NASAL MEDIUM
00763000578060 - N/A2024-09-24 SPLINT 1528137 25PK EXTERNAL NASAL LARGE

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