RecoverPad

Basic Information

• Brand Name: RecoverPad
• Primary DI: 00851610008036
• Version / Model: REPS1515
• Catalog Number: REPS1515
• Company Name: SAUVRE INTERNATIONAL, LTD.
• Labeler DUNS: 080557421
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-19
• Public Version: 5
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: ada99fc9-60cc-42d1-8ba3-e0f344d681f9
• Distribution End Date: 2020-09-17

Device Description

Transcutaneous electrical stimulation electrode, Square, 40x40mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851610008095	GS1	Box	92	Not in Commercial Distribution	2020-09-17
Package	00851610008098	GS1	Bag	8	Not in Commercial Distribution	2020-09-17
Primary	00851610008036	GS1
Package	10851610008088	GS1	Box	88	Not in Commercial Distribution	2020-09-17
Package	00851610008081	GS1	Bag	20	Not in Commercial Distribution	2020-09-17
Package	10851610008071	GS1	Box	44	Not in Commercial Distribution	2020-09-17
Package	00851610008074	GS1	Bag	44	Not in Commercial Distribution	2020-09-17

Device Sizes

Type	Value	Unit	Text
Length	40	Millimeter
Width	40	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 45 Degrees Celsius