FDA UDI
In Commercial Distribution
🇺🇸 United States
SB 5010 ES
DI: 04260647941579
·
Model: 649.000000
·
AKRUS GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SB 5010 ES
- Primary DI
- 04260647941579
- Version / Model
- 649.000000
- 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
- 9f28e2cb-39d8-42f7-9bf4-fc46f12c2329
Device Description
The mobile, electrically operated SB 5010 HS / ES surgical bed is designed for the placement and positioning of patients in the required posture during diagnostic and therapeutic proce-dures, as well as during surgical interventions on humans.
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 |
|---|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38447 | General examination/treatment chair, electric | A mains electricity (AC-powered) 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; it may have an integrated weighing scale. 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 | 04260647941579 | GS1 |
Customer Contacts
- Phone
- +494121791930
- [email protected]