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Navitor™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

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

Identifiers

Catalog Number
NVTR-LS-SM FDA UDI
Primary DI / UDI-DI
05415067036667 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

Navitor™ 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

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Manufacturer

Sources (1)

  • FDA UDI 6566aca0-3407-42f9-94a6-b5d012db8522 35 fields · synced May 30, 2026