GUDID 20643169938520

ELECTRODE 8227130 25PK NDL 1.5MM RD ROHS

MEDTRONIC XOMED, INC.

Subdermal needle electrode
Primary Device ID20643169938520
NIH Device Record Key77be5aa0-9041-41af-be7c-38bd6f204b69
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8227130
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
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 Dimensions

Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter
Length1.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169938526 [Primary]
GS120643169938520 [Package]
Contains: 00643169938526
Package: PK [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZELECTRODE, NEEDLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-26

Devices Manufactured by MEDTRONIC XOMED, INC.

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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

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