AccessGUDID - DEVICE: HAND-TROL GOLD LINE (30653405008266)

GUDID

Device Identifier (DI) Information

Brand Name: HAND-TROL GOLD LINE
Version or Model: 60-0300-501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-0300-501
Company Name: Conmed Corporation

Primary DI Number: 30653405008266
Issuing Agency: GS1
Commercial Distribution End Date: July 05, 2017
Device Count: 50
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE

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?
61869	Open-surgery electrosurgical handpiece/electrode, monopolar, single-use	A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWG	ELECTROSURGICAL DEVICE

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 [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
Handling Environment Temperature: between -34 and 65 Degrees Celsius
Storage Environment Humidity: between 5 and 70 Percent (%) Relative Humidity
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 105ba2e4-9ec2-4180-82fd-2e465aad5324
Public Version Date: February 07, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016