AccessGUDID - DEVICE: S2 Mini Foot Pedal (J00754520070001)

GUDID

Device Identifier (DI) Information

Brand Name: S2 Mini Foot Pedal
Version or Model: 1600983
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1600983-001
Company Name: Bien-Air Surgery SA

Primary DI Number: J00754520070001
Issuing Agency: HIBCC
Commercial Distribution End Date: February 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 481597719 *Terms of Use

Device Description: No description.

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?
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
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 3008fb71-cb3e-4c75-a6b3-2d6e77c0eae4
Public Version Date: February 13, 2023
Public Version Number: 2
DI Record Publish Date: January 07, 2019