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Tendyne™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Tendyne™ FDA UDI
Generic Name
Cardiovascular implant implantation tool base FDA UDI
Device Name
Stand FDA UDI
Model / Reference
TENDV-ST FDA UDI
Description
Stand FDA UDI

Identifiers

Catalog Number
TENDV-ST FDA UDI
Primary DI / UDI-DI
05415067032096 FDA UDI
PMA Number
P240042 FDA UDI
FDA Product Code
NPU FDA UDI
GMDN Term
Cardiovascular implant implantation tool base FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cardiovascular implant implantation tool base

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

Similar devices

Also classified as Cardiovascular implant implantation tool base.

Cleared under the same submission

P240042 also covers:

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 a7e8c195-3834-48bf-a578-ed3b1ef60283 36 fields · synced Jun 8, 2026