AccessGUDID - DEVICE: AqaNife (04260206311065)

GUDID

Device Identifier (DI) Information

Brand Name: AqaNife
Version or Model: 3.0 mm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 200.53.04
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206311065
Issuing Agency: GS1
Commercial Distribution End Date: November 17, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use
Previous DI: 04260206310419

Device Description: The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle without risk of dislocating during the dissection • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection

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
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141790	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
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 15 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: working length 220 cm
Device Size Text, specify: needle length 3.0 mm
Device Size Text, specify: working channel diameter 2.8 mm

Device Record Status

Public Device Record Key: 7365e397-0896-48a5-96c5-252b8831dc6d
Public Version Date: August 07, 2024
Public Version Number: 6
DI Record Publish Date: October 02, 2018