FDA UDI
In Commercial Distribution
🇺🇸 United States
Setmark
DI: 00854204008344
·
Model: DC-104
·
SETMARK INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Setmark
- Primary DI
- 00854204008344
- Version / Model
- DC-104
- Company Name
- SETMARK INC.
- Labeler DUNS
- 080798558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-15
- Public Version
- 1
- Public Version Date
- 2024-10-23
- Public Version Status
- New
- Public Device Record Key
- 277cb0b8-62a7-4bd2-b21a-6fe1b98c6550
Device Description
Arm for Doctor's Stool stainless steel - w/ padded armrests - dark blue
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| FZM | Stool, Operating-Room | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42812 | Chair/stool armrest | A device designed to be attached to a chair or a stool to provide the occupant with arm support for comfort while sitting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854204008344 | GS1 |