AccessGUDID - DEVICE: Wireless Footswitch 12-functions (07630003581034)

GUDID

Device Identifier (DI) Information

Brand Name: Wireless Footswitch 12-functions
Version or Model: 000000000010448872
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Leica Microsystems (Schweiz) AG

Primary DI Number: 07630003581034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480198725 *Terms of Use

Device Description: Wireless Footswitch 12-functions Type B - Accessory for Leica surgical operating microscope systems

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?
35191	General-purpose surgical microscope	A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPT	MICROSCOPE, SURGICAL

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
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: 75739e78-ea5f-4504-84f9-1d72cb88a20a
Public Version Date: June 23, 2021
Public Version Number: 1
DI Record Publish Date: June 15, 2021