AccessGUDID - DEVICE: OptiCross™ 6 (00191506035433)

GUDID

Device Identifier (DI) Information

Brand Name: OptiCross™ 6
Version or Model: H7495181360
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H7495181360
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506035433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Coronary Imaging Catheter

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?
44141	Intravascular ultrasound imaging catheter, single-use	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBJ	Catheter, ultrasound, intravascular
ITX	Transducer, ultrasonic, diagnostic

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Shaft Length: 135 Centimeter
Outer Diameter: 1.18 Millimeter
Device Size Text, specify: 3.6 F Diameter

Device Record Status

Public Device Record Key: 45d1de3e-7718-4df4-bbbb-2921730b11a0
Public Version Date: September 29, 2023
Public Version Number: 1
DI Record Publish Date: September 21, 2023