AccessGUDID - DEVICE: TAMARIN BLUE PTCA RX Dilatation Catheter (06091403537259)

GUDID

Device Identifier (DI) Information

Brand Name: TAMARIN BLUE PTCA RX Dilatation Catheter
Version or Model: DSC2_25X15US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NATEC MEDICAL LTD

Primary DI Number: 06091403537259
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 565545733 *Terms of Use

Device Description: TAMARIN BLUE PTCA RX Coronary Dilatation Catheter, 2.25 X 15 MM/ Shaft length 140 CM

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?
47732	Coronary angioplasty balloon catheter, basic	A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. 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 [?]
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
Handling Environment Temperature: between 15 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry and keep away from sunlight and humidity.

Clinically Relevant Size

[?]

Size Type Text
Balloon Diameter: 2.25 Millimeter
Balloon Length: 15 Millimeter

Device Record Status

Public Device Record Key: cd5496bb-0308-4f9b-9786-26db2e153f61
Public Version Date: April 03, 2025
Public Version Number: 1
DI Record Publish Date: March 26, 2025