AccessGUDID - DEVICE: Pathfinder® Endoscope Overtube (00850006222100)

GUDID

Device Identifier (DI) Information

Brand Name: Pathfinder® Endoscope Overtube
Version or Model: GI 085160-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GI 085160-2
Company Name: NEPTUNE MEDICAL INC.

Primary DI Number: 00850006222100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075588994 *Terms of Use

Device Description: No description.

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?
46687	Endoscopic overtube, single-use	A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	Endoscopic Access Overtube, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211301	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 85 Centimeter
Catheter Working Length: 75 Centimeter
Outer Diameter: 18.5 Millimeter

Device Record Status

Public Device Record Key: 2d5607e2-94b2-4177-b64b-f38b7cd3d189
Public Version Date: June 15, 2021
Public Version Number: 1
DI Record Publish Date: June 07, 2021