FDA UDI
Not in Commercial Distribution
🇺🇸 United States
De Soutter Medical
DI: 05051471176379
·
Model: 19770
·
DE SOUTTER MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- De Soutter Medical
- Primary DI
- 05051471176379
- Version / Model
- 19770
- Catalog Number
- 19770
- Company Name
- DE SOUTTER MEDICAL LIMITED
- Labeler DUNS
- 458064144
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-25
- Public Version
- 2
- Public Version Date
- 2023-01-13
- Public Version Status
- Update
- Public Device Record Key
- 20173594-c347-4b20-b931-426a5a9f54eb
- Distribution End Date
- 2023-01-12
Device Description
PS8 POWER SUPPLY
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| LGH | Instrument, Cast Removal, Ac-Powered | Orthopedic | 888.5960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36545 | Basic power supply, reusable | A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051471176379 | GS1 |