FDA UDI
In Commercial Distribution
🇺🇸 United States
Intelli-C Accessory
DI: 05713464000411
·
Model: 03284050
·
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
- 05713464000411
- Version / Model
- 03284050
- 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
- 2021-04-16
- Public Version
- 1
- Public Version Date
- 2021-04-26
- Public Version Status
- New
- Public Device Record Key
- 58279745-9fae-45f6-8b84-7d9d2031de4b
Device Description
Radiation Shield with Top shield for the Intelli-C X-ray system. A lead curtain for protection against stray radiation during x-ray examination. A cover above the table protects the user against stray radiation from the patient.
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 |
|---|---|---|---|---|
| 38375 | Radiation shielding curtain | A flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713464000411 | GS1 |
Customer Contacts
- Phone
- +4586283500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173631 | 000 |