AccessGUDID - DEVICE: iSnare (00724995180812)

GUDID

Device Identifier (DI) Information

Brand Name: iSnare
Version or Model: 00711088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711088
Company Name: US Endoscopy

Primary DI Number: 00724995180812
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 00816765010938

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
FDI	SNARE, FLEXIBLE
FBK	endoscopic injection needle, gastroenterology-urology

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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Width: 2.5 Millimeter
Needle Gauge: 25 Gauge
Length: 230 Centimeter

Device Record Status

Public Device Record Key: 314bcfd8-0b72-4aed-b2c8-83496168aefb
Public Version Date: November 10, 2020
Public Version Number: 2
DI Record Publish Date: March 19, 2020