FDA UDI
In Commercial Distribution
🇺🇸 United States
EnvoyCem®
DI: 00812282020375
·
Model: 1640
·
Envoy Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EnvoyCem®
- Primary DI
- 00812282020375
- Version / Model
- 1640
- Catalog Number
- 901640-103
- Company Name
- Envoy Medical Corporation
- Labeler DUNS
- 939725313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f98fba45-2d82-4031-a99d-f1750f6a5c02
Device Description
EnvoyCem® Glass Ionmer Cement
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
- No
- 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 |
|---|---|---|---|---|
| NEA | Cement, Ear, Nose And Throat | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16704 | Glass ionomer dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). 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 | 00812282020375 | GS1 |
Customer Contacts
- Phone
- 6513618000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080032 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, Handle with Care
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius