FDA UDI
In Commercial Distribution
🇺🇸 United States
AKRUS
DI: 04260647943573
·
Model: Patient Support System LSCneo
·
AKRUS GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AKRUS
- Primary DI
- 04260647943573
- Version / Model
- Patient Support System LSCneo
- Company Name
- AKRUS GmbH & Co. KG
- Labeler DUNS
- 324099522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-04
- Public Version
- 1
- Public Version Date
- 2023-12-12
- Public Version Status
- New
- Public Device Record Key
- 771eedfc-d423-4497-9fdd-fabe9cb52475
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 |
|---|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43383 | Ophthalmic operating table, electromechanical | An electrically-powered motorized table designed to support a patient during ophthalmic surgical procedures. It is adjustable to accommodate various positions (e.g., height, tilt). It is particularly intended to provide support for and stabilization of the head of the patient (typically includes a headrest) and to help provide optimal access for the surgeon(s) during the intervention (e.g., by having a small-width table top and therefore a shorter stretch distance for the surgeon). It may be freestanding or connected to another device or system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260647943573 | GS1 |