Identity
- Trade Name
- LLD #2 Lead Locking Device FDA UDI
- Generic Name
- Pacing/defibrillation lead stylet FDA UDI
- Model / Reference
- 518-022 FDA UDI
Identifiers
- Catalog Number
- 518-022 FDA UDI
- Primary DI / UDI-DI
- 00813132023027 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
- Outer Diameter — 0.012 Inch FDA UDI
Category: Pacing/defibrillation lead stylet
LLD #2 Lead Locking Device by Spectranetics Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
Sources (2)
- FDA UDI 13cbbedd-4ddc-4b32-80ea-d1a0907ffe3a 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026