AccessGUDID - DEVICE: Selethru NC PTCA Balloon Dilatation Catheter (06971591765699)

GUDID

Device Identifier (DI) Information

Brand Name: Selethru NC PTCA Balloon Dilatation Catheter
Version or Model: KNC225015
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kossel Medtech (Suzhou) Co., Ltd.

Primary DI Number: 06971591765699
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560219894 *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?
17521	Coronary angioplasty balloon catheter, perfusing	A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon. The tube contains holes proximal and distal to the balloon that permit blood flow to the distal coronary arteries during balloon dilatation to protect the myocardium from haemodynamic compromise. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211393	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
No Device Sizes

Device Record Status

Public Device Record Key: 55ac7c3e-45da-4ee3-914f-be178695b642
Public Version Date: September 28, 2021
Public Version Number: 1
DI Record Publish Date: September 20, 2021