AccessGUDID - DEVICE: Electrophysiology Cable (08714729861874)

GUDID

Device Identifier (DI) Information

Brand Name: Electrophysiology Cable
Version or Model: M0046610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M0046610
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729861874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: CONTROLLER TO PUMP OR REMOTE CONTROL

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:	No
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?
47249	Cardiac ablation system cable, reusable	An insulated electrical conductor used to provide an electrical connection between a cardiac tissue ablation system generator and the operative ablative device (e.g., a dedicated cardiac tissue ablation system applicator or a catheter). Its length may also allow the operative ablative device to remain in the sterile field. The electrical conductor is typically made of robust materials with metal connectors [e.g., gold (Au) plated electrical connecting pins and sockets] for reliability. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 610 cm Length

Device Record Status

Public Device Record Key: 9dd04eda-d3b5-4ebb-823e-d6a6141b9e8a
Public Version Date: September 02, 2024
Public Version Number: 4
DI Record Publish Date: January 27, 2015