AccessGUDID - DEVICE: TrapIT (08718481740279)

GUDID

Device Identifier (DI) Information

Brand Name: TrapIT
Version or Model: TRP10015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRP10015
Company Name: IMDS Operations B.V.

Primary DI Number: 08718481740279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 489997508 *Terms of Use

Device Description: The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.

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:	No
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
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191229	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: a5c71e2e-5ab3-4292-979b-eb8c7611324d
Public Version Date: September 09, 2022
Public Version Number: 1
DI Record Publish Date: September 01, 2022