AccessGUDID - DEVICE: ELMED (00842180106802)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: 5984
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5984
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180106802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: "ELMED SYSTEM FOR BIPOLAR SUBMUCOSAL TURBINATE SURGERY CONSISTING OF: LIST NO. 5300 ELMED BC 50 M/M GENERATOR, LIST NO. 5970 DENNIS TURBINATE PROBE, LIST NO. 5707 FOOTSWITCH, LIST NO. 5302 BIPOLAR RF-CABLE, LIST NO. 55200-03 STERILIZATION AND STORAGE CASE AND LIST NO. 5975 INSTRUCTIONAL VIDEO TAPE"

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:	No
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?
11490	Electrosurgical system generator	An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWA	Unit, Electrosurgical Andcoagulation, With Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 0df510a6-ee76-4d7e-a083-2a4b3351c603
Public Version Date: April 04, 2023
Public Version Number: 3
DI Record Publish Date: December 28, 2016