AccessGUDID - DEVICE: POWERPRO (20845854028626)

GUDID

Device Identifier (DI) Information

Brand Name: POWERPRO
Version or Model: PRO6135
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PRO6135
Company Name: Conmed Corporation

Primary DI Number: 20845854028626
Issuing Agency: GS1
Commercial Distribution End Date: December 03, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: POWERPRO ELECTRIC II RECIPROCATOR HANDPIECE

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 -4 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e8126ba-ac3e-4229-8f82-36317b2aa7ae
Public Version Date: September 19, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2016