Identity
- Trade Name
- Lead Adapter FDA UDI
- Generic Name
- Pacing/defibrillation lead electrical adaptor FDA UDI
- Device Name
- Bipolar bifurcated lead to IS-1 bipolar implantable connector. FDA UDI
- Model / Reference
- 501205 FDA UDI
- Description
- Bipolar bifurcated lead to IS-1 bipolar implantable connector. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821329900259 FDA UDI
- FDA Product Code
- DTD FDA UDI
- GMDN Term
- Pacing/defibrillation lead electrical adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3620 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 15 Centimeter FDA UDILumen/Inner Diameter — 5 Millimeter FDA UDI
Category: Pacing/defibrillation lead electrical adaptor
Lead Adapter by Greatbatch Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pacing/defibrillation lead electrical adaptor.
- BIS/BIS-17 — Oscor Inc. · Class II
- C/IS-10 — Oscor Inc. · Class II
- Lead Adaptor Bipolar/Unipolar — Oscor Inc. · Class II
- Lead Adaptor — Oscor Inc. · Class II
- IS1-C5PS — BIOTRONIK SE & Co. KG · Class II
- Lead Adaptor — Oscor Inc. · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class III
- MC01B20 — Oscor Inc. · Class II
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
- Greatbatch Ltd
Sources (1)
- FDA UDI c8e1c244-19cb-468c-8c0d-75fb564b08bc 35 fields · synced Jun 8, 2026