AccessGUDID - DEVICE: POWERSPEED AS1 (04055207056660)

GUDID

Device Identifier (DI) Information

Brand Name: POWERSPEED AS1
Version or Model: 2305001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2305001
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207056660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: MOTOR CONTROL UNIT 2305 for Orthopedics, Spine surgery and Bronchoscopy, for connection of motor handle M4. M5/0. M5/3. S1. M1 and High-Speed Motor X1, connection for two handpieces and a footswitch, 6.5" Touch Screen color display, compatible with core nova, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 300x159.5x404mm

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
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
GEY	MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff3b224c-4536-47d4-bb63-ea6685387c3c
Public Version Date: November 21, 2024
Public Version Number: 4
DI Record Publish Date: July 08, 2024