FDA UDI
In Commercial Distribution
🇺🇸 United States
Grid entity
DI: 04260502640197
·
Model: WR
·
PROTEC GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Grid entity
- Primary DI
- 04260502640197
- Version / Model
- WR
- Catalog Number
- 7051-0-0154
- Company Name
- PROTEC GmbH & Co. KG
- Labeler DUNS
- 314629130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-17
- Public Version
- 1
- Public Version Date
- 2019-12-25
- Public Version Status
- New
- Public Device Record Key
- 7ab1f05a-f744-401d-8415-946fd8fce5ba
Device Description
X-ray film cassette holder
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 |
|---|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | Radiology | 892.1880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14473 | X-ray film cassette holder | A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260502640197 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 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