FDA UDI
In Commercial Distribution
🇺🇸 United States
Codonics Horizon® Multi-media Imager
DI: 00814905020199
·
Model: 54C
·
CODONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Codonics Horizon® Multi-media Imager
- Primary DI
- 00814905020199
- Version / Model
- 54C
- Company Name
- CODONICS INC.
- Labeler DUNS
- 101533727
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 4
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 6c9b9937-217c-4252-9dc6-fc296a57433b
Device Description
Grayscale/Color Desktop Small Format Film and Paper Diagnostic Imager - 54C
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | Radiology | 892.2040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35580 | Diagnostic-imaging multiformat camera | An electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814905020199 | GS1 |
Customer Contacts
- Phone
- 4402431334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021054 | 000 |