AccessGUDID - DEVICE: AGENT™ (00191506014728)

GUDID

Device Identifier (DI) Information

Brand Name: AGENT™
Version or Model: H7493960815220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H7493960815220
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506014728
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Paclitaxel-Coated Balloon 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:	Yes
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?
62218	Coronary angioplasty balloon catheter, drug-coated	A flexible tube with a drug coating at its distal end designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate an atherosclerotic stenotic coronary artery by controlled inflation of a distal distensible balloon, and to simultaneously release a drug intended to inhibit restenosis. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. It may be available as an over-the-wire (OTW) or a rapid exchange (RX) type, and devices to assist catheterization may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOB	Drug-eluting percutaneous transluminal coronary angioplasty catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P230035	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
Balloon Diameter: 2.25 Millimeter
Balloon Length: 15 Millimeter

Device Record Status

Public Device Record Key: b416f621-b46b-40ed-916b-dc72ac9dd4f9
Public Version Date: March 29, 2024
Public Version Number: 1
DI Record Publish Date: March 21, 2024