AccessGUDID - DEVICE: CONMED (30653404046687)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 138652A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 138652A
Company Name: Conmed Corporation

Primary DI Number: 30653404046687
Issuing Agency: GS1
Commercial Distribution End Date: June 25, 2018
Device Count: 40
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: CONMED GOLDLINE FOOT CONTROLLED WITH NEEDLE ELECTRODE SAFETY HOLSTER AND 10 FOOT (3M) CABLE, 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
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Temperature: between -34 and 65 Degrees Celsius
Handling Environment Humidity: between 0 and 50 Percent (%) Relative Humidity
Storage Environment Humidity: between 5 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Meter
Length: 10 Feet

Device Record Status

Public Device Record Key: b3e2dc1a-265e-4d20-8f58-5f587428dab4
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016