FDA UDI
In Commercial Distribution
🇺🇸 United States
Coulmed
DI: 10810087352131
·
Model: 168-2
·
Coulmed Products Group LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Coulmed
- Primary DI
- 10810087352131
- Version / Model
- 168-2
- Catalog Number
- 168-2
- Company Name
- Coulmed Products Group LLC
- Labeler DUNS
- 047115479
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-06
- Public Version
- 1
- Public Version Date
- 2023-01-16
- Public Version Status
- New
- Public Device Record Key
- d65cae2c-e3e8-4f22-bb81-ecdd634cd3cb
Device Description
Revolving Stool Cushion, Non-Conductive, 13' Dia., 1 Inch thick, Standard Black
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
- No
- 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 |
|---|---|---|---|---|
| 34982 | Stool cushion | A soft pillow or pad used to provide support and comfort to the user while sitting on a stool. The device may also be used to elevate the user by increasing the height of the seat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810087352131 | GS1 |