AccessGUDID - DEVICE: ADVANTAGE (20845854035006)

GUDID

Device Identifier (DI) Information

Brand Name: ADVANTAGE
Version or Model: D9924
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D9924
Company Name: Conmed Corporation

Primary DI Number: 20845854035006
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ADVANTAGE TURBO 2-BUTTON SHAVER

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?
53617	Arthroscopic shaver system handpiece, electrically-powered	A handle with attached cutting blade that is a component of an electrically-powered arthroscopic shaver system designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEY	MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 42559bcf-e60f-404e-b874-eff73cbdc4df
Public Version Date: December 05, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016