AccessGUDID - DEVICE: EL Lightwave (20653405059735)

GUDID

Device Identifier (DI) Information

Brand Name: EL Lightwave
Version or Model: EL-2000-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EL-2000-S
Company Name: Conmed Corporation

Primary DI Number: 20653405059735
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2023
Device Count: 1000
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: LIGHTWAVE SUCTION ABLATOR, EXTENDED LENGTH, CONMED

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
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083281	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8be40e36-7fc5-4be4-ba7a-f07c4b405166
Public Version Date: August 20, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2016