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Mts™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
MTS™ FDA UDI
Generic Name
Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator FDA UDI
Device Name
Multiprogram Trial Stimulator FDA UDI
Model / Reference
3510 FDA UDI
Description
Multiprogram Trial Stimulator FDA UDI

Identifiers

Catalog Number
3510 FDA UDI
Primary DI / UDI-DI
05414734402392 FDA UDI
510(k) Number
K033757 FDA UDI
FDA Product Code
GZB FDA UDI
GMDN Term
Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5880 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

Mts™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator.

Cleared under the same submission

K033757 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI b82ddb22-cbc6-4dea-a8fe-774a160efb1e 37 fields · synced May 30, 2026