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SunMed

FDA UDI

Class II (US FDA UDI)

by SunMed

Identity

Trade Name
SunMed FDA UDI
Generic Name
Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Device Name
SunStim Pro Silicone Wrap - Blue FDA UDI
Model / Reference
8-1053-BL FDA UDI
Description
SunStim Pro Silicone Wrap - Blue FDA UDI

Identifiers

Catalog Number
8-1053-BL FDA UDI
Primary DI / UDI-DI
10889483171394 FDA UDI
510(k) Number
K121743 FDA UDI
FDA Product Code
BXN FDA UDI
GMDN Term
Block-monitoring peripheral nerve electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2775 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Block-monitoring peripheral nerve electrical stimulation system

SunMed by SunMed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Block-monitoring peripheral nerve electrical stimulation system.

Cleared under the same submission

K121743 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SunMed

Sources (1)

  • FDA UDI 022e8408-3d5d-4b23-848a-31e21d15d304 36 fields · synced May 30, 2026