AccessGUDID - DEVICE: SET Rotarex™S 8 F x 110 cm (07640142811886)

GUDID

Device Identifier (DI) Information

Brand Name: SET Rotarex™S 8 F x 110 cm
Version or Model: 80239
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80239
Company Name: Straub Medical AG

Primary DI Number: 07640142811886
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488489766 *Terms of Use

Device Description: Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.

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?
59225	Mechanical atherectomy system catheter/handpiece	A sterile catheter with attached handpiece, with a power-driven cutting or abrasive head intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. The operator regulates the energy via a remote control or foot-switch attached to the generator. The handpiece may also serve as a conduit for irrigation, aspiration and placement of a guidewire during surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCW	Catheter, Peripheral, Atherectomy
DQX	Wire, Guide, Catheter

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French
Catheter Working Length: 110 Centimeter

Device Record Status

Public Device Record Key: 76f71ad4-e301-4b56-92df-51989d3a734e
Public Version Date: January 29, 2025
Public Version Number: 3
DI Record Publish Date: May 04, 2022