Identity
- Trade Name
- D2-Kit FDA UDI
- Generic Name
- Endocardial defibrillation lead FDA UDI
- Model / Reference
- 75 FDA UDI
Identifiers
- Catalog Number
- 384135 FDA UDI
- Primary DI / UDI-DI
- 04035479143466 FDA UDI
- PMA Number
- P980023 FDA UDI
- FDA Product Code
- NVY FDA UDI
- GMDN Term
- Endocardial defibrillation lead FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Category: Endocardial defibrillation lead
D2-Kit by BIOTRONIK SE & Co. KG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P980023 also covers:
- BK-IS4/DF4 — BIOTRONIK SE & Co. KG
- BS DF-1 — BIOTRONIK SE & Co. KG
- D2-Kit — BIOTRONIK SE & Co. KG
- D2-Kit — BIOTRONIK SE & Co. KG
- DH DF4 — BIOTRONIK SE & Co. KG
- EFH-30 — BIOTRONIK SE & Co. KG
- IS1-C5PS — BIOTRONIK SE & Co. KG
- IS4/DF4 Adapter — BIOTRONIK SE & Co. KG
- IS4/DF4 Adapter — BIOTRONIK SE & Co. KG
- PA 10 — BIOTRONIK SE & Co. KG
- PA-2 — BIOTRONIK SE & Co. KG
- Pamira S DX 65/15 — BIOTRONIK SE & Co. KG
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
- BIOTRONIK SE & Co. KG
Sources (1)
- FDA UDI 271a5595-b4e4-4266-a136-8f13031e1cc0 36 fields · synced May 30, 2026