FDA UDI
In Commercial Distribution
🇺🇸 United States
FireCam HD Intraoral Camera
DI: 08809466040610
·
Model: FR61
·
Digiray Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FireCam HD Intraoral Camera
- Primary DI
- 08809466040610
- Version / Model
- FR61
- Company Name
- Digiray Corp.
- Labeler DUNS
- 557815751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-30
- Public Version
- 5
- Public Version Date
- 2020-02-07
- Public Version Status
- Update
- Public Device Record Key
- 5e0eaaf6-1430-4f76-90e6-e7345ff9a825
Device Description
The advanced camera & optics technology of the FireCam HD IntraOral Camera enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost. The design features a 360° touch-switch for capture operation.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32265 | Surgical video camera | An electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809466040610 | GS1 |
Customer Contacts
- Phone
- 0427103763
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 2.3 | Centimeter | |
| Length | 23 | Centimeter | |
| Width | 1.8 | Centimeter | |
| Weight | 120 | Gram |