Identity
- Trade Name
- PEMCO INC FDA UDI
- Generic Name
- Vascular irrigation cannula, coronary artery, reusable FDA UDI
- Device Name
- Perfusion Cannula. Tube Handle 9.5 inches long. Style # 8 Fixed Tip - 3 MM Tip Diameter. 120 Degree Bend. Also available in: Large, Flag, & Small, Handle Styles FDA UDI
- Model / Reference
- 1580-T-08-3MM-120 FDA UDI
- Description
- Perfusion Cannula. Tube Handle 9.5 inches long. Style # 8 Fixed Tip - 3 MM Tip Diameter. 120 Degree Bend. Also available in: Large, Flag, & Small, Handle Styles FDA UDI
Identifiers
- Catalog Number
- 1580-T-08-3MM-120 FDA UDI
- Primary DI / UDI-DI
- B1521580T083MM1200 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Vascular irrigation cannula, coronary artery, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDIAngle — 120 degree FDA UDILength — 9.5 Inch FDA UDI
Category: Vascular irrigation cannula, coronary artery, reusable
Pemco Inc by Pemco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Pemco, Inc.
Sources (1)
- FDA UDI 4a0007a1-62a6-4971-8f7a-cb85be61cc5b 36 fields · synced Jun 1, 2026