Identity
- Trade Name
- SureCUT FDA UDI
- Generic Name
- Suture cutter, single-use FDA UDI
- Device Name
- A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device. FDA UDI
- Model / Reference
- 5001 FDA UDI
- Description
- A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 5001 FDA UDI
- Primary DI / UDI-DI
- M95550010 FDA UDI
- FDA Product Code
- FZT FDA UDI
- GMDN Term
- Suture cutter, single-use 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: Suture cutter, single-use
SureCUT by Sentreheart, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture cutter, single-use.
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- SofTIP — ATRICURE, INC. · Class II
- SureCUT — ATRICURE, INC. · Class I
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- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Sklar® — Sklar Corporation · Class I
- NovoCut — Smith & Nephew, 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
- Sentreheart, Inc
Sources (1)
- FDA UDI b336dc25-a4c8-4d47-b6d3-b6e206de321f 35 fields · synced May 29, 2026