Identity
- Trade Name
- Cap and Sleeve Kit FDA UDI
- Generic Name
- Pacing/defibrillation lead electrical adaptor FDA UDI
- Device Name
- Lead adapter cap and sleeve kit. FDA UDI
- Model / Reference
- 501207 FDA UDI
- Description
- Lead adapter cap and sleeve kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821329900273 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pacing/defibrillation lead electrical adaptor
Cap and Sleeve Kit by Greatbatch Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 61ab4f44-3e80-4cd0-abe1-c5e322c4180c 34 fields · synced Jun 8, 2026