AccessGUDID - DEVICE: Accu2i (H787900601US0)

GUDID

Device Identifier (DI) Information

Brand Name: Accu2i
Version or Model: 900-601-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ANGIODYNAMICS UK LIMITED

Primary DI Number: H787900601US0
Issuing Agency: HIBCC
Commercial Distribution End Date: October 21, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 211086221 *Terms of Use

Device Description: Microwave Tissue Ablation Applicator

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?
40792	Microwave hyperthermia system applicator, intracorporeal	A component of a microwave hyperthermia system designed to be placed inside the body to deliver microwave energy to produce a systemic or local heating effect. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of microwave energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the device during operation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

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 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 29 Centimeter

Device Record Status

Public Device Record Key: fea9a95a-1642-430e-986c-05137308f5df
Public Version Date: October 26, 2021
Public Version Number: 3
DI Record Publish Date: September 21, 2016