AccessGUDID - DEVICE: TriClip™ (05415067047755)

GUDID

Device Identifier (DI) Information

Brand Name: TriClip™
Version or Model: TCDS0301-XTW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TCDS0301-XTW
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067047755
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: G4 Delivery System

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?
57790	Heart valve clip	An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPS	Tricuspid valve repair device, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Length: 12.0000 Millimeter
Depth: 6.0000 Millimeter
Width: 22.0000 Millimeter

Device Record Status

Public Device Record Key: 363dfde6-393d-479d-9c42-db7a15ba2a56
Public Version Date: November 11, 2024
Public Version Number: 2
DI Record Publish Date: April 12, 2024

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: Yes
Serial Number: No
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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