Identity
- Trade Name
- GlideLight Laser Sheath EUDAMEDFDA UDI
- Generic Name
- Pacing lead extraction kit, single-use FDA UDI
- Device Name
- GlideLight Laser Sheath EUDAMED
- Model / Reference
- 500-302 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 500-302 FDA UDI
- Primary DI / UDI-DI
- 00813132020330 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132020330 EUDAMED
- FDA Product Code
- MFA FDA UDI
- EMDN Code
- C01901903 VESSEL HARVESTING SYSTEMS EUDAMED
- GMDN Term
- Pacing lead extraction kit, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 0.192 Inch FDA UDILength — 50 Centimeter FDA UDI
GlideLight Laser Sheath by Spectranetics Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132020330 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (2)
- EUDAMED 2de6f426-a074-4e34-9df9-e8260d3ae097 61 fields · synced Jul 15, 2026
- FDA UDI 2462bb3f-2c1f-4ec3-9dfc-a1c9a42a9b71 36 fields · synced May 30, 2026