AccessGUDID - DEVICE: COOLFLEX E9000 (30845854035492)

GUDID

Device Identifier (DI) Information

Brand Name: COOLFLEX E9000
Version or Model: E9010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E9010
Company Name: Conmed Corporation

Primary DI Number: 30845854035492
Issuing Agency: GS1
Commercial Distribution End Date: August 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: COOLFLEX E9000 HIGH SPEED DRILL

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?
66243	Bone/joint surgical power tool motorized handpiece/set, electric, reusable	An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	ARTHROSCOPE

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d64c2a2a-23e7-4498-a9a3-24f963152be1
Public Version Date: September 19, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016