AccessGUDID - DEVICE: SpeedControl SC1 (M-UK1023) (J021303870021)

GUDID

Device Identifier (DI) Information

Brand Name: SpeedControl SC1 (M-UK1023)
Version or Model: 30387002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: W & H Dentalwerk Bürmoos GmbH

Primary DI Number: J021303870021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300238441 *Terms of Use

Device Description: Medical Surgical Unit (230V) for RIWOSpine

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?
41264	Surgical power tool system control unit, line-powered	A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
DZI	Drill, Bone, Powered
GEY	Motor, Surgical Instrument, Ac-Powered
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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: 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: a98e57aa-1106-4ff9-a8f0-71e808b399ac
Public Version Date: October 20, 2023
Public Version Number: 1
DI Record Publish Date: October 12, 2023