AdvanTrode

GUDID 00677346320651

2" x 2" (5cm x 5cm) Square

PEPIN MANUFACTURING, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00677346320651
• NIH Device Record Key: 5aa55827-d35c-44a8-b9db-5c7cf8d41b9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdvanTrode
• Version Model Number: SSB22
• Company DUNS: 807703996
• Company Name: PEPIN MANUFACTURING, INC.
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677346300653 [Unit of Use]
GS1	00677346310652 [Primary]
GS1	00677346320651 [Package]; Contains: 00677346310652; Package: Bag [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070807

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-05

On-Brand Devices [AdvanTrode]

• 00677346310843: Multi-Kit Tricot
• 00677346310836: Multi-Kit Tricot
• 00677346320941: 1.5" x 2.5" (4cm x 6.5cm) Oval White Spunlace
• 00677346320934: 1.875" Rd Conductive Fabric
• 00677346320736: Butterfly w/ Lead Connector
• 00677346320729: 1" Rd w/ lead connector
• 00677346320712: .8" Rd. w/ Lead Connector
• 00677346320705: Butterfly w/ Mini-Snap Connector
• 00677346320699: 1" Round w/ Mini-Snap Connector
• 00677346320682: .8" Round w/ Mini-Snap Connector
• 00677346320675: 1.875" x 5" (4.8cm x 12.7cm) Square
• 00677346320668: 1.875" x 1.875" (4.8cm x4.8cm) Square
• 00677346320651: 2" x 2" (5cm x 5cm) Square
• 00677346320637: 2" x 4" (5cm x 10cm) Rectangle
• 00677346320620: 2" x 2" (5cm x 5cm) Square
• 00677346320613: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle - No Gel
• 00677346320606: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle
• 00677346320590: 1.75" x 1.75" (4.5cm x 4.5cm) Square - No Gel
• 00677346320583: 1.75" x 1.75" (4.5cm x 4.5cm) Square
• 00677346320576: 3" (7.5cm) Round
• 00677346320569: 2" x 4" (5cm x 10cm) Oval
• 00677346320552: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle
• 00677346320545: 2" x 2" (5cm x 5cm) Square
• 00677346320538: 2" (5cm) Round
• 00677346320521: 3" x 5" (7.5cm x 13cm) Rectangle
• 00677346320514: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle with Snap
• 00677346320507: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle
• 00677346320491: 1.75" x 1.75" (4.5cm x 4.5cm) Square with Snap
• 00677346320484: 1.75" x 1.75" (4.5cm x 4.5cm) Square
• 00677346320460: 13" x 1.5" (33cm x 4cm) Backlasp
• 00677346320453: 5" x 8" (13cm x 20cm) Rectangle
• 00677346320446: 4.25" x 7" (11cm x 18cm) Rectangle
• 00677346320439: 4" x 6" (10cm x 15cm) Butterfly
• 00677346320422: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle
• 00677346320415: 2" x 2" (5cm x 5cm) Square
• 00677346320408: 2" (5cm) Round
• 00677346320392: 3" x 5" (7.5cm x 13cm) Rectangle
• 00677346320385: 3" (7.5cm) Round
• 00677346320378: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle
• 00677346320361: 2" x 4" (5cm x 10cm) Oval
• 00677346320354: 1.5" x 2.5" (4cm x 6.5cm) Oval
• 00677346320347: 2" x 2" (5cm x 5cm) Square
• 00677346320330: 2" (5cm) Round
• 00677346320323: 4.25" x 7" (11cm x 18cm) Rectangle
• 00677346320316: 3" x 5" (7.5cm x 13cm) Oval
• 00677346320309: 3" x 5" (7.5cm x 13cm) Rectangle
• 00677346320293: 3" (7.5cm) Round
• 00677346320286: 2" x 4" (5cm x 10cm) Oval
• 00677346320279: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle
• 00677346320262: 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle with Snap