Freedom Stim

GUDID 00677346320835

2" x 3.5" Butterfly w/ Lead

PEPIN MANUFACTURING, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00677346320835
NIH Device Record Key4eb144a5-d0a3-4a20-9f29-aa0823152630
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreedom Stim
Version Model NumberTF900L
Company DUNS807703996
Company NamePEPIN MANUFACTURING, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100677346300776 [Unit of Use]
GS100677346310775 [Primary]
GS100677346320811 [Package]
Contains: 00677346310775
Package: [12 Units]
In Commercial Distribution
GS100677346320828 [Package]
Contains: 00677346310775
Package: [50 Units]
In Commercial Distribution
GS100677346320835 [Package]
Contains: 00677346310775
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-19

On-Brand Devices [Freedom Stim]

006773463210162" x 3.5" Butterfly w/Snap
006773463209272" x 3.5" Butterfly w/ Snap
006773463208972" x 3.5" Butterfly w/ Snap
006773463208662"x 3.5" Pediatric Butterfly w/ Snap
006773463208352" x 3.5" Butterfly w/ Lead
006773463208042"x 3.5" Butterfly w/ Snap
006773463207742" x 3.5" Pediatric Butterfly w/ Snap
006773463207672" x 3.5" Butterfly w/ snap

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