FDA UDI
In Commercial Distribution
🇺🇸 United States
IMPRESS-RITE 380
DI: 00818524020646
·
Model: IMP-7005
·
CROWN DELTA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- IMPRESS-RITE 380
- Primary DI
- 00818524020646
- Version / Model
- IMP-7005
- Catalog Number
- IMP-7005
- Company Name
- CROWN DELTA CORPORATION
- Labeler DUNS
- 030479000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-05
- Public Version
- 3
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- a73e59d4-3726-49fc-bcf5-3cc1cf3ac144
Device Description
M&S DENTAL IMPRESS-RITE 380 MONOPHASE REGULAR SET STARTER KIT
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00818524020646 | GS1 | ||||
| Package | 10818524020643 | GS1 | KIT | 1 | In Commercial Distribution | |
| Package | 20818524020640 | GS1 | CASE | 8 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 73 Degrees Fahrenheit