AccessGUDID - DEVICE: The Advantage Polyp Trap-Quad Chamber Polyp Trap (00677964054945)

GUDID

Device Identifier (DI) Information

Brand Name: The Advantage Polyp Trap-Quad Chamber Polyp Trap
Version or Model: 100104
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 100104
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964054945
Issuing Agency: GS1
Commercial Distribution End Date: May 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: The Advantage Polyp Trap-Quad Chamber Polyp Trap

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):	No
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?
46454	Gastrointestinal/airway foreign body retrieval basket, single-use	A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: c289cd60-ded0-4034-a03f-11cf625dc6b4
Public Version Date: May 26, 2022
Public Version Number: 4
DI Record Publish Date: April 30, 2021