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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 90 Centimeter FDA UDI
Exclaim™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063080 also covers:
P010032 also covers:
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- Eon Mini™ — ST. JUDE MEDICAL, INC.
- Eon Mini™ — ST. JUDE MEDICAL, INC.
- Eon™ — ST. JUDE MEDICAL, INC.
- Exclaim™ — ST. JUDE MEDICAL, INC.
- Genesis™ — ST. JUDE MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI babd685b-e8a6-4ab4-92e4-f8644e9b1c25 38 fields · synced May 30, 2026