FDA UDI
In Commercial Distribution
🇺🇸 United States
Doctor stool ak 445
DI: 04260647945812
·
Model: 280.001008
·
AKRUS GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Doctor stool ak 445
- Primary DI
- 04260647945812
- Version / Model
- 280.001008
- Company Name
- AKRUS GmbH & Co. KG
- Labeler DUNS
- 324099522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-28
- Public Version
- 1
- Public Version Date
- 2025-12-08
- Public Version Status
- New
- Public Device Record Key
- d990fea4-1f55-40bb-bea0-036ebea14974
Device Description
The doctor's stools are chairs for supporting medical activities carried out in a seated position. Surgical procedures in the fields of neurology and cardiology are excluded. The doctor's stools (ak445, ak446, ak447) and surgeon's chairs (ak480) are ergonomically designed chairs for seated medical activities. The product is suitable for use in the immediate patient environment. The chairs are not approved for transporting people.
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
- Yes
- 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 |
|---|---|---|---|---|
| 34833 | General-purpose stool/chair | A seat, usually height-adjustable, intended to be occupied by staff or patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). It is not dedicated to a specific clinical specialty, procedure, or location. It may be used in a healthcare facility, office, or in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260647945812 | GS1 |
Customer Contacts
- Phone
- +494121791930
- [email protected]