AccessGUDID - DEVICE: Rotator (00816765011027)

GUDID

Device Identifier (DI) Information

Brand Name: Rotator
Version or Model: 00711121
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711121
Company Name: US Endoscopy

Primary DI Number: 00816765011027
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The Rotator Snare Mini-Oval is an electrosurgical devices used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy.

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":	Yes
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?
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDI	SNARE, FLEXIBLE

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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 1 Centimeter
Length: 230 Centimeter
Outer Diameter: 2.4 Millimeter

Device Record Status

Public Device Record Key: f3447d54-0738-44e6-8bd8-e70c53f88f1a
Public Version Date: August 07, 2024
Public Version Number: 7
DI Record Publish Date: September 17, 2016