FDA UDI
In Commercial Distribution
🇺🇸 United States
Preat
DI: 00842092182703
·
Model: 9005253
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Preat
- Primary DI
- 00842092182703
- Version / Model
- 9005253
- Catalog Number
- 9005253
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-10
- Public Version
- 1
- Public Version Date
- 2025-06-18
- Public Version Status
- New
- Public Device Record Key
- f1f8c23e-a11d-4079-96f6-2286f0e6386a
Device Description
ASC BioHorizons 3.0mm-Compatible Titanium Screw
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| NHA | Abutment, implant, dental, endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61647 | Dental prosthesis/implant abutment screw | A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092182703 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183518 | 000 |