DEVICE: INTERSTIM® II (00643169974760)

Device Identifier (DI) Information

INTERSTIM® II
3058
Not in Commercial Distribution

MEDTRONIC, INC.
00643169974760
GS1
October 25, 2022
1
796986144 *Terms of Use
INS 3058 INTERSTIM II EMAN US GRC
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
61391 Implantable incontinence-control electrical stimulation system pulse generator
A sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
EZW Stimulator, electrical, implantable, for incontinence
QON Implanted electrical device intended for treatment of fecal incontinence
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P080025 154
P970004 259
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -18 and 52 Degrees Celsius
Storage Environment Temperature: between 0 and 125 Degrees Fahrenheit
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Clinically Relevant Size

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

837a5598-7ceb-406d-9721-9a8ef5ae2b1a
December 23, 2022
2
May 24, 2019
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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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