FDA UDI
In Commercial Distribution
🇺🇸 United States
Implant Prosthetics
DI: 00842092123737
·
Model: 9000500
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Implant Prosthetics
- Primary DI
- 00842092123737
- Version / Model
- 9000500
- Catalog Number
- 9000500
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-28
- Public Version
- 6
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 660a897d-4f46-4789-8cc4-aded386f271f
Device Description
NobelBiocare™ Tri-Lobe-compatible RP 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 |
|---|---|---|---|---|
| 61642 | Dental implant analog | A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092123737 | GS1 | ||||
| Package | 00842092181225 | GS1 | Pack | 25 | In Commercial Distribution | |
| Package | 00842092181218 | GS1 | Pack | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 (800) 232-7732
- [email protected]