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Asahi Sasuke

FDA UDI

Class II (US FDA UDI)

by Asahi Intecc Co., Ltd.

Identity

Trade Name
ASAHI SASUKE FDA UDI
Generic Name
Coronary artery infusion catheter FDA UDI
Model / Reference
SA145-33N FDA UDI

Identifiers

Primary DI / UDI-DI
04547327120197 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Coronary artery infusion catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 3.3 French FDA UDI
Length — 145 Centimeter FDA UDI

Category: Coronary artery infusion catheter

Asahi Sasuke by Asahi Intecc Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary artery infusion catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (1)

  • FDA UDI 759ddd7f-975c-4491-88de-19870a746370 33 fields · synced Jun 8, 2026