FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Preat
DI: 00842092175583
·
Model: 0102003
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Preat
- Primary DI
- 00842092175583
- Version / Model
- 0102003
- Catalog Number
- 0102003
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-25
- Public Version
- 5
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 4aee7b84-4dac-43e3-bf3f-0bc9bdc9118c
- Distribution End Date
- 2023-04-04
Device Description
Preci Post Lab refill. Kit Contains:. 50 Yellow Transparent Burn Out Posts (00842092175521). 50 Blue Transparent Burn Out Posts (00842092175538)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ELR | POST, ROOT CANAL | Dental | 872.3810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45650 | Root canal post kit | A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092175583 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]