Identity
- Trade Name
- BK-IS FDA UDI
- Generic Name
- Pacing/defibrillation lead cap FDA UDI
- Model / Reference
- 109185 FDA UDI
Identifiers
- Catalog Number
- 109185 FDA UDI
- Primary DI / UDI-DI
- 04035479144753 FDA UDI
- 510(k) Number
- K970204 FDA UDI
- FDA Product Code
- DTD FDA UDI
- GMDN Term
- Pacing/defibrillation lead cap 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
No
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
Category: Pacing/defibrillation lead cap
Bk-Is by BIOTRONIK SE & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pacing/defibrillation lead cap.
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- BK-IS4/DF4 — BIOTRONIK SE & Co. KG · 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 II | Pending data |
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Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
Sources (1)
- FDA UDI 24b25c7c-6aec-4c77-bd02-b37a16d2acdf 35 fields · synced May 30, 2026