AccessGUDID - DEVICE: Large Bore 60 cc Syringe (00850291007697)

GUDID

Device Identifier (DI) Information

Brand Name: Large Bore 60 cc Syringe
Version or Model: 99-102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99-102
Company Name: INARI MEDICAL INC

Primary DI Number: 00850291007697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076827459 *Terms of Use
Previous DI: 00850291007178

Device Description: Large Bore 60 cc Syringe

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?
65282	Thrombectomy manual aspirator	A manually-powered, syringe-like device designed specifically to aspirate clotted blood (e.g., thrombi, emboli), or other formed elements, from vessels of the arterial and venous systems to treat vascular obstruction and restore blood flow. The device plunger is withdrawn by the user to generate a negative pressure for aspiration, and collection containers and tubing may be included; it is typically intended to be connected to a patient contact catheter (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy
QEW	Peripheral Mechanical Thrombectomy With Aspiration

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
No Device Sizes

Device Record Status

Public Device Record Key: 68cb3834-6842-42d3-b143-90bf3867199b
Public Version Date: April 01, 2025
Public Version Number: 2
DI Record Publish Date: December 20, 2024