FDA UDI
Not in Commercial Distribution
🇺🇸 United States
3i Certain
DI: 00842092104644
·
Model: 8002800
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3i Certain
- Primary DI
- 00842092104644
- Version / Model
- 8002800
- Catalog Number
- 8002800
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-24
- Public Version
- 5
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- e76ed7c1-89f7-47c9-8ce8-e9174c4a8d61
- Distribution End Date
- 2023-09-22
Device Description
3i 5.0mm Ex Hex Analog
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, implant, dental, endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63663 | Dental implant suprastructure reamer guiding pin | A manually-operated dental laboratory instrument intended to be inserted into a cannulated reamer to help guide the reamer during smoothing and refining of the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, to remove minor casting flashes during the production of a final suprastructure; it is not intended for intraoral use. Also known as a guide pin, it is a metallic cylindrical rod and is available in various diameters and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092104644 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]