AccessGUDID - DEVICE: ENDOGATOR Kit (00677964059636)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOGATOR Kit
Version or Model: 100602
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100602
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964059636
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: ENDOGATOR Kit contains the ENDOGATOR Irrigation Tubing for Boston Scientific ENDOSTAT II, Olympus OFP and ENDO STRATUS Irrigation Pumps and the ENDO SMARTCAP Rinse and Insufflation Tubing for certain Olympus GI Endoscopes

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	endoscopic irrigation/suction system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102855	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
No Device Sizes

Device Record Status

Public Device Record Key: acd6eb3b-b3e3-43d7-ad81-b9139d92de32
Public Version Date: July 19, 2023
Public Version Number: 2
DI Record Publish Date: July 05, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20677964067284	2	10677964059633		In Commercial Distribution	Box
10677964059633	10	00677964059636		In Commercial Distribution	Pouch
20677964059630	30	00677964059636	2023-07-18	Not in Commercial Distribution	Case