DEVICE: Uni-Patch (00884521582104)

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Device Record History
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Device Identifier (DI) Information
Uni-Patch
EP85875
Not in Commercial Distribution
EP85875
Cardinal Health, Inc.
00884521582104
GS1
May 08, 2025
4
080935429 *Terms of Use
C Series Spunlace Electrodes O-T-C
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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?
35995 Transcutaneous electrical stimulation electrode, single-use
An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GXY ELECTRODE, CUTANEOUS
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: No;
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Clinically Relevant Size

[?]
Size Type Text
Length: 2 Inch
Width: 2 Inch
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Device Record Status
6659561f-efee-4643-a1b3-b749db1ff0c7
May 09, 2025
7
July 05, 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
00884521582111 999 00884521582104 2025-05-08 Not in Commercial Distribution CASE
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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: 00884521746124 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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