FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PROGNOST XS
DI: 04260502640357
·
Model: table top 196,3x65,5cm composite fiber
·
PROTEC GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PROGNOST XS
- Primary DI
- 04260502640357
- Version / Model
- table top 196,3x65,5cm composite fiber
- Catalog Number
- 7034-0-0000
- Company Name
- PROTEC GmbH & Co. KG
- Labeler DUNS
- 314629130
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-15
- Public Version
- 2
- Public Version Date
- 2021-12-14
- Public Version Status
- Update
- Public Device Record Key
- 6ca81dfa-eed5-4b2d-84bf-d5fcf6a6d51b
- Distribution End Date
- 2021-10-21
Device Description
Basic diagnostic x-ray system table, non-powered
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 |
|---|---|---|---|---|
| KXJ | Table, Radiologic | Radiology | 892.1980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40654 | Basic diagnostic x-ray system table, non-powered | A non-powered table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260502640357 | GS1 | ||||
| Previous | 04260502640043 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 70 Degrees Celsius