Neuspera SNM System

GUDID 00850075633012

External Nerve Stimulator Kit

NeuSpera Medical Inc.

Transcutaneous incontinence-control electrical stimulator

• Primary Device ID: 00850075633012
• NIH Device Record Key: 4b25fe0b-8058-424d-a723-e2dc6e934bed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuspera SNM System
• Version Model Number: ESK-1
• Company DUNS: 033985298
• Company Name: NeuSpera Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850075633012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240031

FDA Product Code

• EZW: Stimulator, Electrical, Implantable, For Incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-25
• Device Publish Date: 2025-11-17

On-Brand Devices [Neuspera SNM System]

• 00850075633074: Wireless Transmitter
• 00850075633050: Patient Controller
• 00850075633005: Sacral Nerve Stimulator Implant Kit
• 00850075633418: Extra Lead
• 00850075633401: Brief, Beige, Right, Size:3XL
• 00850075633395: Brief, Beige, Right, Size:2XL
• 00850075633388: Brief, Beige, Right, Size:XL
• 00850075633371: Brief, Beige, Right, Size:L
• 00850075633364: Brief, Beige, Right, Size:M
• 00850075633357: Brief, Beige, Right, Size:S
• 00850075633340: Brief, Beige, Right, Size:XS
• 00850075633333: Brief, Beige, Left, Size:3XL
• 00850075633326: Brief, Beige, Left, Size:2XL
• 00850075633319: Brief, Beige, Left, Size:XL
• 00850075633302: Brief, Beige, Left, Size:L
• 00850075633296: Brief, Beige, Left, Size:M
• 00850075633289: Brief, Beige, Left, Size:S
• 00850075633272: Brief, Beige, Left, Size:XS
• 00850075633265: Women's Low-Rise Hipster, Right, 3XL
• 00850075633258: Women's Low-Rise Hipster, Right, 2XL
• 00850075633241: Women's Low-Rise Hipster, Right, XL
• 00850075633234: Women's Low-Rise Hipster, Right, L
• 00850075633227: Women's Low-Rise Hipster, Right, M
• 00850075633210: Women's Low-Rise Hipster, Right, S
• 00850075633203: Women's Low-Rise Hipster, Right, XS
• 00850075633197: Women's Low-Rise Hipster, Left, 3XL
• 00850075633180: Women's Low-Rise Hipster, Left, 2XL
• 00850075633173: Women's Low-Rise Hipster, Left, XL
• 00850075633166: Women's Low-Rise Hipster, Left, L
• 00850075633159: Women's Low-Rise Hipster, Left, M
• 00850075633142: Women's Low-Rise Hipster, Left, S
• 00850075633128: External Stimulator
• 00850075633111: Intraoperative Cable
• 00850075633104: Foramen Needle Set
• 00850075633098: Trial Lead
• 00850075633067: Clinician Programmer
• 00850075633043: Trial Lead Kit
• 00850075633036: Women's Low-Rise Hipster, Left, XS
• 00850075633029: Procedural Accessories Kit
• 00850075633012: External Nerve Stimulator Kit