AccessGUDID - DEVICE: LigaSure Precise (10884524001463)

GUDID

Device Identifier (DI) Information

Brand Name: LigaSure Precise
Version or Model: LS1200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LS1200
Company Name: Covidien LP

Primary DI Number: 10884524001463
Issuing Agency: GS1
Commercial Distribution End Date: February 03, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Tissue Fusion Open Instrument

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 [?]
K010010	000

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
Special Storage Condition, Specify: ;
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 17 Centimeter

Device Record Status

Public Device Record Key: bb92be87-26ba-427d-bd07-7e2ff4da1c6f
Public Version Date: June 24, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016