FDA UDI
In Commercial Distribution
🇺🇸 United States
Intraoral Camera
DI: 06970873260310
·
Model: Ordinary model, standard model, luxury model
·
DENJOY DENTAL CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Intraoral Camera
- Primary DI
- 06970873260310
- Version / Model
- Ordinary model, standard model, luxury model
- Company Name
- DENJOY DENTAL CO.,LTD
- Labeler DUNS
- 529329650
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-19
- Public Version
- 1
- Public Version Date
- 2022-02-28
- Public Version Status
- New
- Public Device Record Key
- 0194f261-2948-4e54-ac43-554df510cda3
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
- Yes
- 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 |
|---|---|---|---|---|
| FTS | Camera, Cine, Endoscopic, With Audio | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47672 | Anorectal mucosa suppository | A device in the form of a tablet or ovule that is inserted into the anorectal canal containing compounds [e.g., hyaluronic acid (HA), plant oil extracts, vitamins] intended to promote and/or expedite the healing, re-epithelialization, protection, and/or soothing of injured, irritated, or inflamed anal-rectal mucosa through various mechanisms (e.g., osmotic properties, lubrication). It may be used following proctological surgery and for proctitis, cryptitis, anal rhagades and fissures, or for other painful conditions. It is intended for use in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970873260310 | GS1 |