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FlexCath Cross Transseptal Solution

FDA UDI

Class II (US FDA UDI)

by Acutus Medical, Inc.

Identity

Trade Name
FlexCath Cross Transseptal Solution FDA UDI
Generic Name
Cardiac transseptal access electrosurgical dilator/needle FDA UDI
Device Name
FlexCath Cross Transseptal Solution– MH 81cm FDA UDI
Model / Reference
900307-003 FDA UDI
Description
FlexCath Cross Transseptal Solution– MH 81cm FDA UDI

Identifiers

Catalog Number
900307-003 FDA UDI
Primary DI / UDI-DI
00850027837888 FDA UDI
FDA Product Code
DYB FDA UDI
DRE FDA UDI
GMDN Term
Cardiac transseptal access electrosurgical dilator/needle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
870.1310 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiac transseptal access electrosurgical dilator/needle

FlexCath Cross Transseptal Solution by Acutus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal access electrosurgical dilator/needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acutus Medical, Inc.

Sources (1)

  • FDA UDI 0359fe67-de66-4215-ae1f-2c3084b74cc0 35 fields · synced May 30, 2026