AccessGUDID - DEVICE: AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating (00813132022891)

GUDID

Device Identifier (DI) Information

Brand Name: AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating
Version or Model: 2216-20100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2216-20100
Company Name: Spectranetics Corporation

Primary DI Number: 00813132022891
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: No description.

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
PNO	Catheter, Percutaneous, Cutting/Scoring

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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Balloon Length: 100 Millimeter
Balloon Diameter: 2.0 Millimeter

Device Record Status

Public Device Record Key: d6f5fcf3-854f-42ad-b2a5-b3cfddb4f14e
Public Version Date: October 21, 2024
Public Version Number: 9
DI Record Publish Date: September 23, 2016