Identity
- Trade Name
- MOND™ FDA UDI
- Generic Name
- Pacing/defibrillation lead stylet FDA UDI
- Device Name
- Stylet kit, wide curve FDA UDI
- Model / Reference
- 4150/65 FDA UDI
- Description
- Stylet kit, wide curve FDA UDI
Identifiers
- Catalog Number
- 4150/65 FDA UDI
- Primary DI / UDI-DI
- 05414734505437 FDA UDI
- 510(k) Number
- K080924 FDA UDI
- FDA Product Code
- DRB FDA UDI
- GMDN Term
- Pacing/defibrillation lead stylet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1380 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 65 Centimeter FDA UDI
Category: Pacing/defibrillation lead stylet
Mond™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pacing/defibrillation lead stylet.
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- SJM™ — ST. JUDE MEDICAL, INC. · Class II
- MOND™ — ST. JUDE MEDICAL, INC. · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class II
- Locator™ — ST. JUDE MEDICAL, INC. · Class III
- Locator™ — ST. JUDE MEDICAL, INC. · Class III
Cleared under the same submission
K080924 also covers:
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — ST. JUDE MEDICAL, INC.
- MOND™ — 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 II | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 03874084-c102-4fcc-a40a-f7d43d044691 38 fields · synced May 30, 2026