Identity
- Trade Name
- SureCUT FDA UDI
- Generic Name
- Pericardioscopic access cannula FDA UDI
- Device Name
- SureCUT Suture Cutter FDA UDI
- Model / Reference
- 50-01 FDA UDI
- Description
- SureCUT Suture Cutter FDA UDI
Identifiers
- Catalog Number
- FG-0006-02 FDA UDI
- Primary DI / UDI-DI
- 10840143904400 FDA UDI
- FDA Product Code
- FZT FDA UDI
- GMDN Term
- Pericardioscopic access cannula FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pericardioscopic access cannula
SureCUT by Atricure, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pericardioscopic access cannula.
- SofTIP — ATRICURE, INC. · Class II
- SureCUT — ATRICURE, INC. · Class I
- SureCUT — ATRICURE, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA UDI 4cb217f3-78a2-4fb4-9f53-ffd8cfc0e19b 35 fields · synced Jun 1, 2026