AccessGUDID - DEVICE: InThrill Thrombectomy Catheter (00810123710126)

GUDID

Device Identifier (DI) Information

Brand Name: InThrill Thrombectomy Catheter
Version or Model: 43-102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 43-102
Company Name: INARI MEDICAL INC

Primary DI Number: 00810123710126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076827459 *Terms of Use
Previous DI: 00850291007352

Device Description: InThrill Thrombectomy Catheter (AS-01312)

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:	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?
61179	Electronic occlusion spectacles	A battery-powered ophthalmic device designed to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes (e.g., presbyopia). It is in the form of spectacles with lenses that can independently be made opaque electronically, so that the stronger eye is occluded to promote use of the weaker eye. It is intended to be used for short intervals (e.g., 15 – 30 minutes), typically at home, and is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEW	Peripheral Mechanical Thrombectomy With Aspiration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250421	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: 9a8ea348-3729-4e97-bbf6-1c965cc79f0c
Public Version Date: June 09, 2025
Public Version Number: 1
DI Record Publish Date: May 30, 2025