AccessGUDID - DEVICE: CONMED (30653405050074)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: AES-50S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AES-50S
Company Name: Conmed Corporation

Primary DI Number: 30653405050074
Issuing Agency: GS1
Commercial Distribution End Date: October 13, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION

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?
61872	Endoscopic electrosurgical electrode, bipolar, single-use	An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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
Special Storage Condition, Specify: KEEP DRY
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -29 and 38 Degrees Celsius
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -29 and 38 Degrees Celsius
Handling Environment Temperature: between -20 and 100 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 100 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Angle: 50 degree
Length: 13 Centimeter

Device Record Status

Public Device Record Key: e68d727f-80b6-489c-8602-61b549cbefdd
Public Version Date: August 20, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016