AccessGUDID - DEVICE: Comet (08714729904410)

GUDID

Device Identifier (DI) Information

Brand Name: Comet
Version or Model: H7493932450
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729904410
Issuing Agency: GS1
Commercial Distribution End Date: April 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Pressure Guidewire

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:	Yes
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?
47486	Intravascular haemodynamic monitoring system guidewire	A sterile, steerable, component of a haemodynamics monitoring system for the in vivo measurement of blood pressure and/or blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically consists of a long, thin, flexible rod that has built-in pressure/flow measuring transducers/sensors at its working end, and a torque device to facilitate navigation through the vasculature; it has a handle at the proximal end and a cable(s) to connect to the monitoring system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXO	TRANSDUCER, PRESSURE, CATHETER TIP

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
Device Size Text, specify: 0.014 in Diameter
Device Size Text, specify: 185 cm Effective Length

Device Record Status

Public Device Record Key: 1db4b571-a54a-41bb-9b96-4bb8e15aab8c
Public Version Date: April 08, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016