DEVICE: InterStim iCon® (00643169860728)

Device Identifier (DI) Information

InterStim iCon®
3037
In Commercial Distribution

MEDTRONIC, INC.
00643169860728
GS1

1
796986144 *Terms of Use
PROG 3037 INTERSTM PATIENT US PTG UPDATE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61396 Implantable incontinence-control electrical stimulation system programmer, battery-powered
A portable, battery-powered external device intended to change, noninvasively, one or more of the operating parameters (the programs) of an implanted incontinence-control electrical stimulation system pulse generator. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provides historic and/or current information regarding the performance of the implant.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EZW Stimulator, electrical, implantable, for incontinence
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970004 248
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -30 and 135 Degrees Fahrenheit
Storage Environment Temperature: between -34 and 57 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

cf768722-40a9-4a00-a591-6bb98e33ab8c
July 06, 2018
3
October 07, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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