AccessGUDID - DEVICE: CONMED ENDOGATOR PUMP (00677964085611)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED ENDOGATOR PUMP
Version or Model: CETEGP-100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CETEGP100
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964085611
Issuing Agency: GS1
Commercial Distribution End Date: February 03, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: CONMED ENDOGATOR PUMP

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:	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?
33579	Surgical irrigation/aspiration pump, reusable	An electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable 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 [?]
K060962	000

Device Exempt from Premarket Submission: No 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: 5a59493c-b93d-453d-ac6e-5431a014ab98
Public Version Date: February 04, 2025
Public Version Number: 6
DI Record Publish Date: September 28, 2018