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Masters Series™

FDA UDI

Class I (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Masters Series™ FDA UDI
Generic Name
Heart valve prosthesis holder, single-use FDA UDI
Device Name
Replacement Holder/Rotators FDA UDI
Model / Reference
M-RHR FDA UDI
Description
Replacement Holder/Rotators FDA UDI

Identifiers

Catalog Number
M-RHR FDA UDI
Primary DI / UDI-DI
05415067042293 FDA UDI
FDA Product Code
DTJ FDA UDI
GMDN Term
Heart valve prosthesis holder, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.3935 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve prosthesis holder, single-use

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

Similar devices

Also classified as Heart valve prosthesis holder, single-use.

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 4ecdae6e-25f9-4aa0-ae35-0357c87605d6 35 fields · synced May 30, 2026