AccessGUDID - DEVICE: Safari Dental Chair (D104SAF1031)

GUDID

Device Identifier (DI) Information

Brand Name: Safari Dental Chair
Version or Model: SAF-103-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Safari Dentaire Inc

Primary DI Number: D104SAF1031
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245011531 *Terms of Use

Device Description: Medical chair without wheels and not electrically powered for use of patients undergoing dental treatment or examination. Solid aluminum frame construction, easy to assemble, no tools needed. Tested to support 400 lbs (182 kg).

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?
38448	General examination/treatment chair, manual	A manually-operated device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRK	Chair, Examination And Treatment

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95648766-2dc2-4018-a2da-d5c87019d190
Public Version Date: October 10, 2023
Public Version Number: 1
DI Record Publish Date: October 02, 2023