AccessGUDID - DEVICE: Gen2 (00840343700348)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2E17055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2E17055
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343700348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use
Previous DI: G277G2E170550

Device Description: HOUSE SUCTION IRRIGATOR 4x5 FR

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:	No
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?
36269	Surgical irrigation/aspiration cannula, illuminating, reusable	An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It has a built-in light or fibreoptic bundle for illumination. The device may incorporate a handle with side valve(s)/hole(s) for the control of irrigation/aspiration, and may be provided with a stylet, sheath, and/or connection tubing. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZF	Tube, Ear Suction

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Gauge 4 French Gauge (FR)
Device Size Text, specify: Gauge 5 French Gauge (FR)
Device Size Text, specify: Length size 5.5 inches

Device Record Status

Public Device Record Key: 239ac1e1-d486-49dc-ab8d-e1bd9b9e2d26
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022