AccessGUDID - DEVICE: OR-VAC (20845854061852)

GUDID

Device Identifier (DI) Information

Brand Name: OR-VAC
Version or Model: OL3MT24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OL3MT24
Company Name: Conmed Corporation

Primary DI Number: 20845854061852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 00815198012779

Device Description: OR-VAC Open Smoke Evacuation Tubing 7/8 in (22 mm) x 10 ft (3.1 m) with 8 in (20 cm) integral wand and sponge guard

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?
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
GAZ	TUBING, NONINVASIVE

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: 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: 0cef2614-9b0c-4bdd-bb7f-67bec2989e7f
Public Version Date: August 13, 2024
Public Version Number: 4
DI Record Publish Date: July 21, 2020