Assistant with StableSoft™ 3L Flex

FDA UDI

Class I (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name: Assistant with StableSoft™ 3L Flex FDA UDI
Generic Name: Coronary artery exposure retractor FDA UDI
Model / Reference: T401213S FDA UDI

Identifiers

Primary DI / UDI-DI: 00699753450929 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Coronary artery exposure retractor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coronary artery exposure retractor

Assistant with StableSoft™ 3L Flex by Terumo Cardiovascular Systems Corporation — 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: Terumo Cardiovascular Systems Corporation

Sources (1)

FDA UDI b3b9304d-9e7d-4609-a65b-fc16ccb92ba2 32 fields · synced Jun 9, 2026