AccessGUDID - DEVICE: ESD AqaNife (04260206310419)

GUDID

Device Identifier (DI) Information

Brand Name: ESD 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: 04260206310419
Issuing Agency: GS1
Commercial Distribution End Date: November 26, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

Device Description: The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection • for thick tissue (needle length of 3.0 mm)

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?
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. 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
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 8ddf53ea-3959-4478-bad2-7f8cf9e91a3a
Public Version Date: October 31, 2019
Public Version Number: 5
DI Record Publish Date: September 16, 2016