Identity
- Trade Name
- SJM™ FDA UDI
- Generic Name
- Implantable electrical stimulation lead suture sleeve FDA UDI
- Device Name
- IS4/DF4 CONNECTOR SLEEVE FDA UDI
- Model / Reference
- EX3151 FDA UDI
- Description
- IS4/DF4 CONNECTOR SLEEVE FDA UDI
Identifiers
- Catalog Number
- EX3151 FDA UDI
- Primary DI / UDI-DI
- 05414734504676 FDA UDI
- PMA Number
- P950022 FDA UDI
- FDA Product Code
- NVY FDA UDI
- GMDN Term
- Implantable electrical stimulation lead suture sleeve 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable electrical stimulation lead suture sleeve
Sjm™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Implantable electrical stimulation lead suture sleeve.
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Cleared under the same submission
P950022 also covers:
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — 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 169a4cbd-912b-470b-9ea3-22e75b7c4c48 37 fields · synced May 29, 2026