Regentex

GUDID 00677346320989

2" x 3.5" Butterfly w/ Snap

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: 00677346320989
• NIH Device Record Key: 4674abba-a0ea-45df-b8bb-efd23e1d59a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regentex
• Version Model Number: 500
• Company DUNS: 807703996
• Company Name: PEPIN MANUFACTURING, INC.
• Device Count: 2
• 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	00677346300837 [Unit of Use]
GS1	00677346310850 [Primary]
GS1	00677346320958 [Package]; Contains: 00677346310850; Package: [12 Units]; In Commercial Distribution
GS1	00677346320965 [Package]; Contains: 00677346310850; Package: [30 Units]; In Commercial Distribution
GS1	00677346320972 [Package]; Contains: 00677346310850; Package: [50 Units]; In Commercial Distribution
GS1	00677346320989 [Package]; Contains: 00677346310850; Package: [100 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: 2017-08-01

Devices Manufactured by PEPIN MANUFACTURING, INC.

• 00677346300868 - AdvanTrode: 2023-12-22 2" Square Hook and Loop
• 00677346320149 - AdvanTrode: 2019-02-06 1.5" x 2" (4cm x 5cm) Rectangle
• 00677346310157 - AdvanTrode: 2019-02-06 1.5" x 2.5" (4cm x 6.5cm) Oval
• 00677346320187 - AdvanTrode: 2019-02-06 3" (7.5cm) Round
• 00677346320217 - AdvanTrode: 2019-02-06 1.75" x 1.75" (4.5cm x 4.5cm) Square with Snap
• 00677346320224 - AdvanTrode: 2019-02-06 1.75" x 1.75" (4.5cm x 4.5cm) Square
• 00677346320231 - AdvanTrode: 2019-02-06 1.5" x 2" (4cm x 5cm) Rectangle
• 00677346320262 - AdvanTrode: 2019-02-06 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle with Snap