FDA UDI
In Commercial Distribution
🇺🇸 United States
Intelli-C Accessory
DI: 05713464000428
·
Model: 03285000
·
Nrt - Nordisk Røntgen Teknik A/S
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Intelli-C Accessory
- Primary DI
- 05713464000428
- Version / Model
- 03285000
- Company Name
- Nrt - Nordisk Røntgen Teknik A/S
- Labeler DUNS
- 307332705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-01
- Public Version
- 1
- Public Version Date
- 2019-05-09
- Public Version Status
- New
- Public Device Record Key
- 7ad43f95-c248-4c31-9baf-b9d18dc3b049
Device Description
Side Bar for the Intelli-C X-ray system. A long side bar to be fixed in any position along the table top designed to support the patient while rolling over for various examinations.
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
- No
- 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 |
|---|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | 892.1650 | 2 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34868 | Bedrail | A rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713464000428 | GS1 |
Customer Contacts
- Phone
- +4586283500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173631 | 000 |