AccessGUDID - DEVICE: SET Aspirex™ S 6F 135cm (07640142811329)

GUDID

Device Identifier (DI) Information

Brand Name: SET Aspirex™ S 6F 135cm
Version or Model: 80325
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80325
Company Name: Straub Medical AG

Primary DI Number: 07640142811329
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488489766 *Terms of Use

Device Description: The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 6F; length 135cm), one Aspirex™ Guidewire (0.018” diameter; 320 cm in length), one collecting bag, and one sterile drape.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
58172	Thrombectomy rotational catheter	A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEW	Peripheral Mechanical Thrombectomy With Aspiration
DQX	Wire, Guide, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220270	000
K230356	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
Catheter Gauge: 6 French
Catheter Working Length: 135 Centimeter

Device Record Status

Public Device Record Key: 7874da76-9840-4f5b-802a-9d982c1d6aae
Public Version Date: April 25, 2025
Public Version Number: 4
DI Record Publish Date: June 30, 2022