Model: 9619-40C
Catalog: 9619-40C
DI: 00850022775260
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
Mounting Pad - Sterile
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
29e01d87-1315-4278-85b9-8ef7015c3352
Distribution Status:
In Commercial Distribution
DUNS Number:
963383778
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
Device ID:
00850022775260
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60959
Name: Analgesic PENS system
Definition:
An assembly of mains electricity (AC-powered) devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). It typically consists of external current generator, return electrode(s), connection cables and a system probe which may be provided separately. It is intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve. It is intended to be used by a healthcare professional in a clinical setting.
FDA Product Codes
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Premarket Submissions
Submission Number:
K223306
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
55
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-20
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
55
Item #2 - Storage Handling Type:
Handling Environment Temperature