DEVICE: INTERSTIM® (20613994926313)

Device Identifier (DI) Information

INTERSTIM®
041828
Not in Commercial Distribution

MEDTRONIC, INC.
20613994926313
GS1
July 30, 2024
6
796986144 *Terms of Use
NEEDLE 041828 3.5 INCH GLOBAL FLEX
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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?
44063 Neurosurgical procedure kit, non-medicated, single-use
A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.
Active false
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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 046
P970004 150
No CLOSE

Sterilization

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

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

[?]
Size Type Text
Length: 9.0 Centimeter
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Device Record Status

18323633-19e2-4703-99e1-f76f982f7460
September 30, 2024
4
September 23, 2014
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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: 00613994926319 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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