Peak Medical

FDA UDI

Class I (US FDA UDI)

by PEAK MEDICAL Distribution Inc

Identity

Trade Name: PEAK MEDICAL FDA UDI
Generic Name: Coronary sinus cannula 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: 24-50300S 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: G4532450300S0 FDA UDI
FDA Product Code: GEA FDA UDI
GMDN Term: Coronary sinus 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Coronary sinus cannula

Peak Medical by PEAK MEDICAL Distribution Inc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: PEAK MEDICAL Distribution Inc

Sources (1)

FDA UDI 495dc522-9539-4f93-9cbd-eaa41729c21b 33 fields · synced Jun 8, 2026