DEVICE: Freedom Stim (00677346310768)

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Device Record History
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Device Identifier (DI) Information
Freedom Stim
TF900S
In Commercial Distribution

PEPIN MANUFACTURING, INC.
00677346310768
GS1

2
807703996 *Terms of Use
2"x 3.5" Butterfly w/ Snap
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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 [?]
K070807 000
No CLOSE

Sterilization
No
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
77b89694-674a-4086-83f3-8dc29d21b734
February 19, 2021
4
January 19, 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
00677346320804 100 00677346310768 In Commercial Distribution
00677346320798 50 00677346310768 In Commercial Distribution
00677346320781 12 00677346310768 In Commercial Distribution
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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: 00677346300769 CLOSE

Direct Marking (DM)

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

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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