AccessGUDID - DEVICE: NA (30653405038768)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 60-6040-436
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-6040-436
Company Name: Conmed Corporation

Primary DI Number: 30653405038768
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5MM X 43CM ALLIS TIP MONOPOLAR DISSECTOR

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?
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943327	000

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

Clinically Relevant Size

[?]

Size Type Text
Length: 43 Centimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 56295380-490e-41c7-81aa-d93ec09de1ab
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016