Mini Sheath with FlexCath Cross

FDA UDI

Class II (US FDA UDI)

by Acutus Medical, Inc.

Identity

Trade Name: Mini Sheath with FlexCath Cross FDA UDI
Generic Name: Cardiac transseptal access set FDA UDI
Device Name: Mini sheath, 65cm – L2 with FlexCath Cross FDA UDI
Model / Reference: 012852-005 FDA UDI
Description: Mini sheath, 65cm – L2 with FlexCath Cross FDA UDI

Identifiers

Catalog Number: 012852-005 FDA UDI
Primary DI / UDI-DI: 00850027837697 FDA UDI
FDA Product Code: DYB FDA UDI
GMDN Term: Cardiac transseptal access set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1340 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cardiac transseptal access set

Mini Sheath with FlexCath Cross by Acutus Medical, 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: Acutus Medical, Inc.

Sources (1)

FDA UDI 0f57f4da-4080-416c-96ef-4ad8265a804d 35 fields · synced Jun 1, 2026