DEVICE: Electrode Skin Prep Pads (00616784150826)

Device Identifier (DI) Information

Electrode Skin Prep Pads
1508
In Commercial Distribution

Dynarex Corporation
00616784150826
GS1

100
008124539 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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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?
47102 Electrode skin abrasion pad
A small, abrasive, hand-held device intended to be rubbed over select skin surface areas of a patient in preparation for placement of electrocardiograph (ECG) electrodes. It is used to remove superficial skin cells to enhance electrical contact (conductivity) for optimal ECG signals. It is typically used by emergency medical services (EMS). This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
KOY Degreaser, Skin, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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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

cc2a4b7f-f19d-4108-a58d-90517e8e4574
October 09, 2024
2
May 10, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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: 00616784150819 CLOSE

Direct Marking (DM)

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

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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