AccessGUDID - DEVICE: iSnare (00816765010945)

GUDID

Device Identifier (DI) Information

Brand Name: iSnare
Version or Model: 00711089
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711089
Company Name: US Endoscopy

Primary DI Number: 00816765010945
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 iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device.

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?
46632	Endoscopic electrosurgical submucosal lift/resection set	A collection of devices designed to be used during an endoscopic mucosal resection procedure to: 1) lift a section of diseased mucosa by injection of a submucosal lifting solution; and 2) resect the lesion using monopolar electrosurgical energy; it may in addition include devices designed to perform vacuum elevation of the lesion to supplement submucosal lifting. It includes a submucosal injection needle, an electrosurgical electrode (e.g., polyp snare), and might include additional supportive devices such as a dye spray catheter and endoscope suction cap. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBK	endoscopic injection needle, gastroenterology-urology
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
Needle Gauge: 23 Gauge
Length: 230 Centimeter
Width: 2.5 Millimeter

Device Record Status

Public Device Record Key: 161268de-d29c-4420-8cf5-c3e8bdbf367b
Public Version Date: March 17, 2020
Public Version Number: 6
DI Record Publish Date: September 17, 2016