FDA UDI
In Commercial Distribution
🇺🇸 United States
Preat
DI: 00842092173299
·
Model: 2RT00H4
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Preat
- Primary DI
- 00842092173299
- Version / Model
- 2RT00H4
- Catalog Number
- 2RT00H4
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-10-24
- Public Version
- 6
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 1cb5f7ec-087d-4b3c-91b0-054c8ec3210f
Device Description
M2 Axial Solder Accessory (2-Pack)
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 |
|---|---|---|---|---|
| EGG | ATTACHMENT, PRECISION, ALL | Dental | 872.3165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45697 | Fixture/appliance dental drill bit, single-use | A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00842092168660 | GS1 | ||||
| Primary | 00842092173299 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]