Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Vascular irrigation cannula, coronary artery, single-use FDA UDI
- Device Name
- Re-usable - Small - Coronary Perfusion Cannula Stainless Steel - 45 degree Angled Shaft, 3.0mm 0 Tip - 4 holes. 24cm overall lenth, suction tube 3mm O.D, 2mm Inside Diameter, Luer Lock Female Connector. FDA UDI
- Model / Reference
- 33-60-3500S FDA UDI
- Description
- Re-usable - Small - Coronary Perfusion Cannula Stainless Steel - 45 degree Angled Shaft, 3.0mm 0 Tip - 4 holes. 24cm overall lenth, suction tube 3mm O.D, 2mm Inside Diameter, Luer Lock Female Connector. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G45333603500S0 FDA UDI
- FDA Product Code
- HXD FDA UDI
- GMDN Term
- Vascular irrigation cannula, coronary artery, 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular irrigation cannula, coronary artery, single-use
Peak Medical by PEAK MEDICAL Distribution Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular irrigation cannula, coronary artery, single-use.
- Ostial Sprit Cannulae — Spyder Medical · Class II
- Coronary Perfusion Cannula — SORIN GROUP ITALIA SRL · Class II
- Coronary Perfusion Cannula — SORIN GROUP ITALIA SRL · Class II
- Coronary Perfusion Cannula — SORIN GROUP ITALIA SRL · Class II
- Ostial Sprit Cannulae — Spyder Medical · Class II
- Ostial Sprit Cannulae — Spyder Medical · Class II
- Coronary Perfusion Cannula — SORIN GROUP ITALIA SRL · Class II
- Coronary Perfusion Cannula — SORIN GROUP ITALIA SRL · Class II
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
- PEAK MEDICAL Distribution Inc
Sources (1)
- FDA UDI 50f7fd8c-3e07-4e41-aadc-87ea07481120 33 fields · synced Jun 1, 2026