AccessGUDID - DEVICE: NA (30653405038256)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 60-6045-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-6045-003
Company Name: Conmed Corporation

Primary DI Number: 30653405038256
Issuing Agency: GS1
Commercial Distribution End Date: October 16, 2024
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5MM X 33CM STRAIGHT FENESTRATED (DUCKBILL) TIP MONOPOLAR GRASPER

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?
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. 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 [?]
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 Temperature: between -29 and 60 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 16 and 27 Degrees Celsius
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 33 Centimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 64ae4f81-1f54-400e-a540-4eeb859bb0c8
Public Version Date: October 17, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016