AccessGUDID - DEVICE: ELMED (00842180104778)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: 5514-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5514-07
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180104778
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: HAND ACTIVATED MONOPOLAR FORCEPS: CUSHING, SERRATED, STRAIGHT TIP 7" (18CM) W/ATTACHED 10-FT. CABLE, TWO PRONG PLUG FOR VALLEY LAB, CONMED, BOVIE, AND ELMED GENERATORS. INDICATE: LIST NO. 5XXX-XX + TIP SIZE (MM) A-2.0, B-1.5, C-1.0, D-0.5, E-NEEDLE (EX: 5XXX-XXA)

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?
61870	Open-surgery electrosurgical handpiece/electrode, monopolar, reusable	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 reusable device.	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: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: e3c4aa43-552b-4b9c-964b-f87359738c16
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 10, 2016