AccessGUDID - DEVICE: Key Surgical Polypectomy Snare (00849771039129)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Polypectomy Snare
Version or Model: EN 10330
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EN10330
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771039129
Issuing Agency: GS1
Commercial Distribution End Date: November 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Polypectomy Snare, Stiff Multi-Wire, Mini-Oval, 10mm W

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?
62615	Mechanical-cutting endoscopic polypectomy snare	A sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGX	Snare, Non-Electrical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 40 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10mm open width

Device Record Status

Public Device Record Key: 5e37c8fa-c7f7-4711-9040-0fac05a49ca0
Public Version Date: November 13, 2023
Public Version Number: 4
DI Record Publish Date: February 12, 2020