AccessGUDID - DEVICE: Lutonix® Drug Coated Balloon (00801741098420)

GUDID

Device Identifier (DI) Information

Brand Name: Lutonix® Drug Coated Balloon
Version or Model: BSCLX35130480
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BSCLX35130480
Company Name: LUTONIX, INC.

Primary DI Number: 00801741098420
Issuing Agency: GS1
Commercial Distribution End Date: November 09, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 946734808 *Terms of Use

Device Description: LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x80mm

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?
62551	Peripheral angioplasty balloon catheter, drug-coated	A sterile, 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, and to simultaneously release a drug intended to inhibit restenosis; 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. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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: Balloon Length, 80 Millimeter
Device Size Text, specify: Balloon Diameter, 4 Millimeter
Device Size Text, specify: Catheter Length, 130 Centimeter

Device Record Status

Public Device Record Key: e66cc55b-f38f-4739-af75-9f5ebff2c063
Public Version Date: April 17, 2024
Public Version Number: 6
DI Record Publish Date: March 24, 2015