AccessGUDID - DEVICE: OPTRELL Mapping Catheter with TRUEref Technology (10846835025811)

GUDID

Device Identifier (DI) Information

Brand Name: OPTRELL Mapping Catheter with TRUEref Technology
Version or Model: D142902
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D142902
Company Name: Biosense Webster Inc

Primary DI Number: 10846835025811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020163218 *Terms of Use

Device Description: OPTRELL-36 F-J Curve

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
46355	Cardiac mapping catheter, percutaneous, single-use	A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTD	Catheter, intracardiac mapping, high-density array

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230253	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
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use if use if box is opened
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Special Storage Condition, Specify: Do not use if package is damaged
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49566cc4-8569-41ed-a507-5234be73d9b8
Public Version Date: October 12, 2023
Public Version Number: 1
DI Record Publish Date: October 04, 2023