AccessGUDID - DEVICE: Smoke Set (15060120959710)

GUDID

Device Identifier (DI) Information

Brand Name: Smoke Set
Version or Model: 2200/47BDKBTUA123/0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2200/47BDK
Company Name: GVS FILTER TECHNOLOGY UK LTD

Primary DI Number: 15060120959710
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 769934225 *Terms of Use

Device Description: The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing noxious chemicals from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision. It is indicated for use during any minimally invasive surgery involving insufflation, laser, or ultrasonic scalpel use. It is recommended that the surgeon and their team wear N95/FFP3 face mask during surgery.

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):	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?
31723	Suction system filter, plume particulate	A screening device installed within the suction tubing line of a suction system, or the suction tubing used with a central vacuum system, to extract particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent clogging of the suction or vacuum system. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs and can be made of translucent plastic, allowing for inspection when in use. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 826ca8a0-a750-4696-8c87-87e6e31a733e
Public Version Date: August 09, 2024
Public Version Number: 1
DI Record Publish Date: August 01, 2024