Model: SP1010
DI: 00858563006157
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
1.0"x1.0" sq. 4 each/PKG
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
464f609c-04ed-4fc4-8b12-e76757eb58c1
Distribution Status:
In Commercial Distribution
DUNS Number:
617940346
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Poly bag
Item #1 - Device ID:
30858563006158
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00858563006157
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00858563006157
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Inner box
Item #3 - Device ID:
40858563006155
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
10
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
30858563006158
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Pkg Type:
Carton Box
Item #4 - Device ID:
50858563006152
Item #4 - Pkg Status:
In Commercial Distribution
Item #4 - Pkg Quantity:
5
Item #4 - Device ID Type:
Package
Item #4 - Contains DINumber:
40858563006155
Item #4 - Device ID Issuing Agency:
GS1
GMDN
Code: 35995
Name: Transcutaneous electrical stimulation electrode, single-use
Definition:
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.
FDA Product Codes
GXY
Electrode, Cutaneous
Premarket Submissions
Submission Number:
K042301
Supplement Number:
000