FDA UDI
In Commercial Distribution
🇺🇸 United States
Enthus
DI: 00353045001878
·
Model: 38-00011
·
DHARMA RESEARCH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Enthus
- Primary DI
- 00353045001878
- Version / Model
- 38-00011
- Catalog Number
- 38-00011
- Company Name
- DHARMA RESEARCH, INC.
- Labeler DUNS
- 078444642
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d9d968e5-0133-4215-9362-11360a66cd5f
Device Description
Enthus Bite Registration, Regular Set, 2 x 50ml Cartridges & 6 Mixing Tips
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10353045001875 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00353045001878 | GS1 | ||||
| Unit of Use | 00353045002752 | GS1 |
Customer Contacts
- Phone
- 8778333725
- [email protected]
- Phone
- +3054829669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 50 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 23 Degrees Celsius