AccessGUDID - DEVICE: Footswitch SupraFuser (07649990202358)

GUDID

Device Identifier (DI) Information

Brand Name: Footswitch SupraFuser
Version or Model: Footswitch SupraFuser
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FS04-002
Company Name: Surgical Fusion Technologies GmbH

Primary DI Number: 07649990202358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482948937 *Terms of Use

Device Description: Footswitch for Ultrasonic Generator

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):	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?
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System
HWC	Screw, Fixation, Bone
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene
MAI	Fastener, Fixation, Biodegradable, Soft Tissue
HTY	Pin, Fixation, Smooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171228	000
K240288	000

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
Handling Environment Temperature: between 50 and 86 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25f208ef-ef37-4043-a1d1-a2bf622ad3c3
Public Version Date: April 15, 2024
Public Version Number: 2
DI Record Publish Date: February 05, 2024