AccessGUDID - DEVICE: Biosense Webster (07613327359923)

GUDID

Device Identifier (DI) Information

Brand Name: Biosense Webster
Version or Model: D7R20P14CT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D7R20P14CT
Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.

Primary DI Number: 07613327359923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020198912 *Terms of Use

Device Description: Diagnostic EP Catheter ISMUS, 7F

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?
46359	Cardiac mapping catheter, percutaneous, reprocessed	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 and cardioversion (CV), and electrophysiology (EP) mapping. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NLH	CATHETER, RECORDING, ELECTRODE, REPROCESSED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012708	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 110.0 Centimeter

Device Record Status

Public Device Record Key: 379d1743-7b07-4194-94a5-7593195ee702
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 16, 2016