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Exclaim™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Exclaim™ FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
Device Name
Lead, 90 cm FDA UDI
Model / Reference
3225 FDA UDI
Description
Lead, 90 cm FDA UDI

Identifiers

Catalog Number
3225 FDA UDI
Primary DI / UDI-DI
05414734401883 FDA UDI
PMA Number
P010032 FDA UDI
510(k) Number
K063080 FDA UDI
FDA Product Code
LGW FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 90 Centimeter FDA UDI

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

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

Similar devices

Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection.

Cleared under the same submission

K063080 also covers:

P010032 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 ab83038c-8401-4fce-b9dc-c00a61a6e2c7 38 fields · synced Jun 8, 2026