Identity
- Trade Name
- Myopore® Sutureless Myocardial Pacing Lead FDA UDI
- Generic Name
- Epicardial pacing lead FDA UDI
- Device Name
- Myopore® Bipolar Sutureless Pacing Lead FDA UDI
- Model / Reference
- 511210 FDA UDI
- Description
- Myopore® Bipolar Sutureless Pacing Lead FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821329900204 FDA UDI
- FDA Product Code
- DTB FDA UDI
- GMDN Term
- Epicardial pacing lead FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.3680 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 — 25 Centimeter FDA UDI
Category: Epicardial pacing lead
Myopore® Sutureless Myocardial Pacing Lead by Greatbatch Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Epicardial pacing lead.
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- Capsure® EPI — MEDTRONIC, INC. · Class III
- Capsure® EPI — MEDTRONIC, INC. · Class III
- Capsure® EPI — MEDTRONIC, INC. · Class III
- Capsure® EPI — MEDTRONIC, INC. · 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
- Greatbatch Ltd
Sources (1)
- FDA UDI 831043be-1b65-41ef-a2f2-952d5cc0b4ab 35 fields · synced Jun 1, 2026