AccessGUDID - DEVICE: UNIVERSAL PLUS (30653405011778)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSAL PLUS
Version or Model: 60-6010-023
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-6010-023
Company Name: Conmed Corporation

Primary DI Number: 30653405011778
Issuing Agency: GS1
Commercial Distribution End Date: December 08, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT HANDLE), STRAIGHT HANDLE ELECTROSURGICAL SUCTION/IRRIGATION INSTRUMENT WITH HAND CONTROLLED ELECTROSURGERY (BUTTONS) AND Y-CONNECTOR SET

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?
57823	Surgical irrigation/aspiration handpiece control valve	A sterile device designed as a push-button valve that is inserted into the control valve seat of a reusable surgical irrigation/aspiration handpiece and when activated by the operator will interrupt the aspiration (suction) and activate the irrigation function (the fluid flow) of the handpiece/system. This provides a high level of hygiene as this device is removed after each application and discarded negating complicated and time-consuming cleaning procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 16 and 27 Degrees Celsius
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf6521f1-4b44-4943-9473-eac336e2df71
Public Version Date: December 08, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016