GUDID 20613994802365

ELECTRODE DME1004 24PK 35X50 2M GND ROHS

MEDTRONIC XOMED, INC.

Subdermal needle electrode
Primary Device ID20613994802365
NIH Device Record Keyefece093-1fd8-4847-8b65-b9464ed65b1c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDME1004
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

Device Dimensions

Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994802361 [Primary]
GS120613994802365 [Package]
Contains: 00613994802361
Package: PK [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYELECTRODE, CUTANEOUS

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 Date2016-04-30

Devices Manufactured by MEDTRONIC XOMED, INC.

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00763000578022 - N/A2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL
00763000578039 - N/A2024-09-24 SPLINT 1528111 5PK EXTERNAL NASAL SMALL

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