FDA UDI
In Commercial Distribution
🇺🇸 United States
NewTom
DI: 08033837931348
·
Model: NewTom VGi evo
·
CEFLA SOCIETA' COOPERATIVA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NewTom
- Primary DI
- 08033837931348
- Version / Model
- NewTom VGi evo
- Catalog Number
- P70700011
- Company Name
- CEFLA SOCIETA' COOPERATIVA
- Labeler DUNS
- 429341410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-03
- Public Version
- 3
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- 1cae24ba-0094-4431-a65a-32a06ed370ee
Device Description
X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display.
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
- 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 |
|---|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61019 | Cone beam computed tomography system, head/neck | A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033837931348 | GS1 |
Customer Contacts
- Phone
- +1 (704)598-0020
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 71 – 106 KiloPascal