FDA UDI In Commercial Distribution 🇺🇸 United States

Duck Intraoral camera model

DI: 04711099370023 · Model: CD1310F6 · OPCOM INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Duck Intraoral camera model
Primary DI
04711099370023
Version / Model
CD1310F6
Company Name
OPCOM INC.
Labeler DUNS
657204525
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-12-20
Public Version
1
Public Version Date
2024-12-30
Public Version Status
New
Public Device Record Key
749b3285-4c8a-4f57-ab20-751955432c01

Device Description

Explore the infinite possibilities that the Duck dental examination series brings to home care: Duck dental mirrors can uncover hidden dental plaque, solve the problem of plaque accumulation, and display areas that require thorough brushing and flossing. Duck intraoral examination mirror monitors the evaluation of braces, implants, and dentures to confirm precise alignment and optimal cleanliness, serving as an early warning system for lesions, ulcers, and mysterious spots The Duck intraoral examination mirror can identify gum inflammation, detect bleeding, and detect abnormal conditions that may indicate gum disease. The Duck intraoral examination mirror will become your oral care mentor, uncovering the intricate veil inside your mouth. Duck dental endoscope enters the world of telemedicine. Obtain expert opinions by sharing images of cavities with dental professionals.

Device Characteristics

Single Use
Yes
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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EAX Mirror, Mouth

GMDN Terms

Code Name
31776 Dental mirror, reusable

Identifiers

Type ID
Primary 04711099370023