FDA UDI
In Commercial Distribution
🇺🇸 United States
VOCO GIC Mixer
DI: 06971503860788
·
Model: A
·
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VOCO GIC Mixer
- Primary DI
- 06971503860788
- Version / Model
- A
- Catalog Number
- Y200F6D490 9050
- Company Name
- E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
- Labeler DUNS
- 526885184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-11
- Public Version
- 1
- Public Version Date
- 2022-04-19
- Public Version Status
- New
- Public Device Record Key
- 0c6ee46f-c226-4305-87d8-64cfbad97ccb
Device Description
A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
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 |
|---|---|---|---|---|
| EFD | Amalgamator, Dental, Ac-Powered | Dental | 872.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10082 | Dental amalgam mixer | A mains electricity (AC-powered) device used to shake a homogenous mixture of fine dental alloy particles [e.g., tin (Sn), silver (Ag), zinc (Zn), or copper (Cu)] with mercury (Hg) to obtain a dental amalgam, typically right before application. The amalgam is usually prepared in an appropriate capsule that may or may not be an integral part of the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971503860788 | GS1 |