FDA UDI
In Commercial Distribution
🇺🇸 United States
LEWIN
DI: 06976041613032
·
Model: CreLife 3000
·
Shandong Lewin Medical Equipment Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LEWIN
- Primary DI
- 06976041613032
- Version / Model
- CreLife 3000
- Company Name
- Shandong Lewin Medical Equipment Co., Ltd.
- Labeler DUNS
- 546175601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-09
- Public Version
- 1
- Public Version Date
- 2023-02-17
- Public Version Status
- New
- Public Device Record Key
- ad778874-3b62-4832-8cec-7f86aff7524e
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33324 | Gynaecological operating table, electromechanical | A mobile, electrically-powered motorized table designed to support a patient during gynaecological surgical procedures. The table surface consists of articulated sections that can be elevated, lowered for contouring, or removed to accommodate various anatomical positions; adjustable leg holders/stirrups are also included either directly attached to the table or to its side rails. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06976041613032 | GS1 |