AccessGUDID - DEVICE: WiSE CRT System (00859244007067)

GUDID

Device Identifier (DI) Information

Brand Name: WiSE CRT System
Version or Model: 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EBR Systems, Inc.

Primary DI Number: 00859244007067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151420580 *Terms of Use

Device Description: Delivery Sheath

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
63187	Left-ventricular wireless pacing system transducer/electrode	A device consisting of an endocardial electrode with an ultrasound transducer intended to be implanted within the left ventricle of the heart to receive ultrasound (US) pulses from a parent transmitter and convert these into electrical pacing impulses to pace the left ventricle for cardiac resynchronization therapy (CRT) with a separate co-implanted pacemaker. It consists of a small electrode with a transducer intended to be attached to the endocardium. It is intended as an alternative to left-ventricular pacing using a coronary venous pacing lead. Disposable devices dedicated to implantation (e.g., delivery catheter) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
SEG	Leadless Cardiac Resynchronization Therapy (Crt)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P240028	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: Devices should be stored in their original packages in a dry, room temperature environment.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de5c99c3-43b0-435b-b79d-c9edc8658fba
Public Version Date: May 15, 2025
Public Version Number: 1
DI Record Publish Date: May 07, 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: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 4087201906
Email: ebr.ra@ebrwise.com

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