AccessGUDID - DEVICE: Tendyne™ (05415067032676)

GUDID

Device Identifier (DI) Information

Brand Name: Tendyne™
Version or Model: TENDV-SPAD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TENDV-SPAD
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067032676
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Apical Pad - Small

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60246	Mitral transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPU	Prosthesis, mitral valve, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P240042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b45f1c01-8595-4aa6-aaf4-1841689a929e
Public Version Date: June 06, 2025
Public Version Number: 1
DI Record Publish Date: May 29, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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