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Peak Medical

FDA UDI

Class I (US FDA UDI)

by PEAK MEDICAL Distribution Inc

Identity

Trade Name
PEAK MEDICAL FDA UDI
Generic Name
Vascular irrigation cannula, coronary artery, single-use FDA UDI
Device Name
Re-usable - medium - 50 degree Angle Shaft with 3.75mm tip Re-usable Stanless Steel Coronary Perfusion Cannula. 24cm overall length, 3mm suction tube O.D.; 2mm I.D. Tip with 4 holes. Female Luer Lock. FDA UDI
Model / Reference
24-50375L FDA UDI
Description
Re-usable - medium - 50 degree Angle Shaft with 3.75mm tip Re-usable Stanless Steel Coronary Perfusion Cannula. 24cm overall length, 3mm suction tube O.D.; 2mm I.D. Tip with 4 holes. Female Luer Lock. FDA UDI

Identifiers

Primary DI / UDI-DI
G4532450375L0 FDA UDI
FDA Product Code
GEA 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
Sterilization Method
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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PEAK MEDICAL Distribution Inc

Sources (1)

  • FDA UDI 3e5c24a4-5366-4add-8a2a-bf026e4dd2c4 33 fields · synced May 30, 2026