DEVICE: NA (00613994571922)

Device Identifier (DI) Information

NA
3550-05
Not in Commercial Distribution

MEDTRONIC, INC.
00613994571922
GS1
May 24, 2023
1
796986144 *Terms of Use
ACC 3550-05 INTERSTIM PERC EXTN BOWEL
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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?
48054 Neural-tissue electrical stimulation lead adaptor
A sterile implantable device intended to provide a functional and modified connection between existing neurostimulation leads and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GZB STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
EZW Stimulator, electrical, implantable, for incontinence
MHY STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
NHL STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
QON Implanted electrical device intended for treatment of fecal incontinence
PJS Stimulator, electrical, implanted, for essential tremor
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P080025 000
P960009 073
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

95a5de31-2cc6-4e53-b228-eb0ea78e35e4
June 26, 2023
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: No Unit of Use DI Numbers Found 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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