FDA UDI
In Commercial Distribution
🇺🇸 United States
Safari Dental Chair
DI: D104SAF1031
·
Model: SAF-103-1
·
Safari Dentaire Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Safari Dental Chair
- Primary DI
- D104SAF1031
- Version / Model
- SAF-103-1
- Company Name
- Safari Dentaire Inc
- Labeler DUNS
- 245011531
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-02
- Public Version
- 1
- Public Version Date
- 2023-10-10
- Public Version Status
- New
- Public Device Record Key
- 95648766-2dc2-4018-a2da-d5c87019d190
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRK | Chair, Examination And Treatment | General Hospital | 880.6140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D104SAF1031 | HIBCC |