Identity
- Trade Name
- SLS II Laser Sheath FDA UDI
- Generic Name
- Pacing lead extraction kit, single-use FDA UDI
- Model / Reference
- 500-013 FDA UDI
Identifiers
- Catalog Number
- 500-013 FDA UDI
- Primary DI / UDI-DI
- 00813132020316 FDA UDI
- FDA Product Code
- MFA FDA UDI
- GMDN Term
- Pacing lead extraction kit, single-use 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 — 0.225 Inch FDA UDILength — 50 Centimeter FDA UDI
Category: Pacing lead extraction kit, single-use
SLS II Laser Sheath by Spectranetics Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pacing lead extraction kit, single-use.
- COOK — COOK VANDERGRIFT INC. · Class II
- SLS II Laser Sheath — Spectranetics Corporation · Class III
- SLS II Laser Sheath — Spectranetics Corporation · Class III
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
- Spectranetics Corporation
Sources (1)
- FDA UDI 1cd507d9-f32a-465a-982e-3c1289e3bf5a 36 fields · synced May 30, 2026