AccessGUDID - DEVICE: HALL MICROFREE MINIDRIVER (20845854605797)

GUDID

Device Identifier (DI) Information

Brand Name: HALL MICROFREE MINIDRIVER
Version or Model: PRO8500SB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PRO8500SB
Company Name: Conmed Corporation

Primary DI Number: 20845854605797
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: HALL MicroFree Mini-Driver

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?
37867	Surgical power tool system handpiece, rotary, rechargeable battery-powered	A hand-held device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. It is powered by an attached rechargeable battery pack to directly provide low-voltage electricity to the motor of the handpiece. The device may be cannulated to allow the use of a guidewire. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HAB	SAW, POWERED, AND ACCESSORIES

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e5718edb-7c56-48b0-a9da-ff2acc5a37fc
Public Version Date: September 21, 2020
Public Version Number: 4
DI Record Publish Date: January 15, 2018