AccessGUDID - DEVICE: Tigereye ST (00851354004554)

GUDID

Device Identifier (DI) Information

Brand Name: Tigereye ST
Version or Model: O350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: O350
Company Name: AVINGER, INC.

Primary DI Number: 00851354004554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003152968 *Terms of Use

Device Description: The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.

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?
46719	Atheroma crossing microdissection catheter, coronary	A manually-powered (non-electronic) instrument intended to be used to create a pathway through an occluded coronary artery to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [chronic total occlusion (CTO)], prior to further percutaneous intervention to remove the lesion. It typically consists of a long, thin, flexible segment, introduced into the vasculature, that is equipped to mechanically disrupt the lesion (e.g., by blunt microdissection) through manipulation of hand controls at the proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDU	Catheter For Crossing Total Occlusions
NQQ	System, Imaging, Optical Coherence Tomography (Oct)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230594	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 11e3c1d4-e760-4cf6-a639-776d428d2649
Public Version Date: August 07, 2024
Public Version Number: 2
DI Record Publish Date: July 24, 2023