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SJM™ Masters Series

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
SJM™ Masters Series FDA UDI
Generic Name
Mitral bi-leaflet mechanical heart valve prosthesis FDA UDI
Device Name
Mitral PTFE Rotatable Mechanical Heart Valve FDA UDI
Model / Reference
27MTJ-503 FDA UDI
Description
Mitral PTFE Rotatable Mechanical Heart Valve FDA UDI

Identifiers

Catalog Number
27MTJ-503 FDA UDI
Primary DI / UDI-DI
05414734053624 FDA UDI
FDA Product Code
LWQ FDA UDI
GMDN Term
Mitral bi-leaflet mechanical heart valve prosthesis 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 27 Millimeter FDA UDI

Category: Mitral bi-leaflet mechanical heart valve prosthesis

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

Similar devices

Also classified as Mitral bi-leaflet mechanical heart valve prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI 9dbbb66f-bea5-464f-808d-df3065b05223 37 fields · synced Jun 1, 2026