AccessGUDID - DEVICE: CORE E3™ (20653405986697)

GUDID

Device Identifier (DI) Information

Brand Name: CORE E3™
Version or Model: CD8300-B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD8300-B
Company Name: Conmed Corporation

Primary DI Number: 20653405986697
Issuing Agency: GS1
Commercial Distribution End Date: April 17, 2024
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Suction/Irrigator, Handpiece only

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?
47890	Disposable surgical irrigation/aspiration system	A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

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

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
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 65 Percent (%) Relative Humidity
Special Storage Condition, Specify: KEEP DRY; KEEP OUT OF SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e330b5a6-ace5-4941-a11e-599475192a4e
Public Version Date: April 18, 2024
Public Version Number: 3
DI Record Publish Date: November 05, 2021