DEVICE: INTERSTIM® (20643169439409)

Device Identifier (DI) Information

INTERSTIM®
357937
In Commercial Distribution

MEDTRONIC, INC.
20643169439409
GS1

6
796986144 *Terms of Use
CABLE 357937 ISTM TEST NO GP 6PK NEW CBL
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrical-only medical device connection cable, reusable A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
P080025 083
P970004 187
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Sterilization

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

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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

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Size Type Text
Length: 37.0 Centimeter
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Device Record Status

ae76e214-d075-44fb-b22a-766152bddc33
July 06, 2018
3
January 03, 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

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

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Unit of Use DI Number: 00643169439405 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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