GUDID 00763000242749

EARPHONES AE102 INSERT ROHS

MEDTRONIC XOMED, INC.

Auditory stimulator
Primary Device ID00763000242749
NIH Device Record Key3e63d9ce-57e7-4613-9b19-07a18a669118
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAE102
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 Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000242749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZELECTRODE, NEEDLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-15
Device Publish Date2019-07-05

Devices Manufactured by MEDTRONIC XOMED, INC.

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00763000835330 - NIM Neuro2025-01-31 PATIENT INTFC 8253410 NIM NEURO 3.0 ROHS
00763000003036 - NIM Vital™2024-11-15 CONN CABLE NIM4CPB2 PAT INTFC NIM 4.0
00763000842543 - Bipolar Stimulating Probe2024-11-04 PROBE 8225351 5PK CONCEN BIPO STIM ROHS
00763000842550 - Bipolar Stimulating Probe2024-11-04 PROBE 8225401 5PK SD-SD BIPOL STIM ROHS
00763000842567 - Bipolar Stimulating Probe2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
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

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