PROG 3037 INTRSTIM II PATIENT 60601-11 Medical Device Identification

GUDID 00643169512955

PROG 3037 INTRSTIM II PATIENT 60601-11

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered

Primary Device ID	00643169512955
NIH Device Record Key	083278a5-2959-44c2-93ce-34cb057a34cd
Commercial Distribution Status	In Commercial Distribution
Version Model Number	3037
Company DUNS	796986144
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169512955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P970004

FDA Product Code

EZW	Stimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-18

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