AccessGUDID - DEVICE: Athletis™ (08714729974109)

GUDID

Device Identifier (DI) Information

Brand Name: Athletis™
Version or Model: H74939347081050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H74939347081050
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729974109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: PTA Balloon Dilatation 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?
17184	Peripheral angioplasty balloon catheter, basic	A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIT	Catheter, angioplasty, peripheral, transluminal

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
Catheter Length: 50 Centimeter
Balloon Diameter: 8.0 Millimeter
Balloon Length: 100 Millimeter

Device Record Status

Public Device Record Key: 57077ace-6ce0-4753-b2ee-abe31e789870
Public Version Date: October 15, 2020
Public Version Number: 1
DI Record Publish Date: October 07, 2020