AccessGUDID - DEVICE: ORI (00854150007286)

GUDID

Device Identifier (DI) Information

Brand Name: ORI
Version or Model: SS-EVAC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SS-EVAC
Company Name: Operating Room Innovations, Inc.

Primary DI Number: 00854150007286
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 080246656 *Terms of Use

Device Description: SmokeStop - Smoke Evacuation Kit

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
46483	Surgical plume evacuation system tube	A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	Accessory, Surgical Apparel

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: db726d93-9640-4566-8936-91a2c0513d95
Public Version Date: July 11, 2025
Public Version Number: 4
DI Record Publish Date: December 29, 2020