← Back to catalogue

FlexNav™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
FlexNav™ FDA UDI
Generic Name
Self-expandable heart valve bioprosthesis collapsing tool, single-use FDA UDI
Device Name
Loading System FDA UDI
Model / Reference
FNAV-LS-SM FDA UDI
Description
Loading System FDA UDI

Identifiers

Catalog Number
FNAV-LS-SM FDA UDI
Primary DI / UDI-DI
05415067031433 FDA UDI
FDA Product Code
NPT FDA UDI
GMDN Term
Self-expandable heart valve bioprosthesis collapsing tool, single-use FDA UDI

Classification

Device Class
Class III 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

Category: Self-expandable heart valve bioprosthesis collapsing tool, single-use

FlexNav™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Self-expandable heart valve bioprosthesis collapsing tool, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI 6a2336fe-65b6-4be6-a975-92655cf9c03b 35 fields · synced Jun 8, 2026