Identity
- Trade Name
- Tapscope FDA UDI
- Generic Name
- Transoesophageal pacing lead FDA UDI
- Device Name
- 10 French esophageal bipolar pacing and recording catheter, (single unit package). FDA UDI
- Model / Reference
- 210, single pack FDA UDI
- Description
- 10 French esophageal bipolar pacing and recording catheter, (single unit package). FDA UDI
Identifiers
- Catalog Number
- 100 FDA UDI
- Primary DI / UDI-DI
- 00856233005028 FDA UDI
- PMA Number
- P860008 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Transoesophageal pacing lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 10 French FDA UDI
Category: Transoesophageal pacing lead
Tapscope by Cardio Command — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transoesophageal pacing lead.
- Tapscope — Cardio Command · Class II
- Tapcath — Cardio Command · Class II
- Tapcath — Cardio Command · Class II
Cleared under the same submission
P860008 also covers:
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
- Cardio Command
Sources (1)
- FDA UDI fe6285f7-5929-46ec-be56-9a50120eda94 37 fields · synced May 30, 2026