AccessGUDID - DEVICE: TracStar LDP Large Distal Platform (00812212030337)

GUDID

Device Identifier (DI) Information

Brand Name: TracStar LDP Large Distal Platform
Version or Model: ICAC088095
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ICAC088095
Company Name: IMPERATIVE CARE, INC.

Primary DI Number: 00812212030337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080816678 *Terms of Use

Device Description: TracStar LDP, 95 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":	Yes
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?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous
QJP	Catheter, Percutaneous, Neurovasculature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212224	000
K240948	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
Special Storage Condition, Specify: Store in a cool, dry place at room temperature.
Special Storage Condition, Specify: Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 0.088 Inch
Outer Diameter: 0.110 Inch
Catheter Length: 95 Centimeter

Device Record Status

Public Device Record Key: 44d40354-cc72-41eb-9f9d-ef6bbcf70803
Public Version Date: February 11, 2025
Public Version Number: 4
DI Record Publish Date: September 22, 2021