TactiSys™ Quartz Equipment

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: TactiSys™ Quartz Equipment FDA UDI
Generic Name: Medical device service rail clamp FDA UDI
Device Name: Tactisys to Precision Above Mounting Bracket FDA UDI
Model / Reference: TSM-ABV-GBL FDA UDI
Description: Tactisys to Precision Above Mounting Bracket FDA UDI

Identifiers

Catalog Number: TSM-ABV-GBL FDA UDI
Primary DI / UDI-DI: 05415067029355 FDA UDI
FDA Product Code: OAE FDA UDI
GMDN Term: Medical device service rail clamp FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical device service rail clamp

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

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Bracket — LivaNova USA, Inc. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
CAPIOX — Terumo Corp. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI 06f6fa3e-02f8-4d62-b711-4fdfad3a7121 35 fields · synced May 30, 2026