FDA UDI
In Commercial Distribution
🇺🇸 United States
Eazipan LC
DI: 08809254454506
·
Model: EP402-S000
·
VERICOM CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Eazipan LC
- Primary DI
- 08809254454506
- Version / Model
- EP402-S000
- Company Name
- VERICOM CO., LTD.
- Labeler DUNS
- 689698269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-02-14
- Public Version
- 1
- Public Version Date
- 2023-02-22
- Public Version Status
- New
- Public Device Record Key
- ba3f9c9d-6f20-4cfa-9df8-0153b37d360f
Device Description
Light curing individual tray resin; Eazipan LC Pink 2 sheet/ container
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBH | Material, Impression Tray, Resin | Dental | 872.3670 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58106 | Dental impression tray material | A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08809254454476 | GS1 | ||||
| Primary | 08809254454506 | GS1 |
Customer Contacts
- Phone
- +82314412881
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius