BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

i900 Series Single Use Tip

DI: 08800026700876 · Model: MO1-ST1 · Medit Corp.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: i900 Series Single Use Tip
Primary DI: 08800026700876
Version / Model: MO1-ST1
Company Name: Medit Corp.
Labeler DUNS: 688800085
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2026-02-03
Public Version: 1
Public Version Date: 2026-02-11
Public Version Status: New
Public Device Record Key: 643cb9e9-391e-4f24-b984-204b1ba4efc1

Device Description

i900 Series Single-Use Tip

Device Characteristics

Single Use: Yes
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: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	872.3661	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63669	Intraoral optical scanning system	An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18800026700873	GS1	Second package	10	In Commercial Distribution
Primary	08800026700876	GS1
Package	28800026700870	GS1	Third package	5	In Commercial Distribution

Customer Contacts

Phone: +82221939600
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -10 – 50 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 20 – 80 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: .8 – 1.1 KiloPascal
Type: Handling Environment Temperature
Temperature Range: 18 – 28 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 20 – 75 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: .8 – 1.1 KiloPascal