FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Preat
DI: 00842092111796
·
Model: 1300352
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Preat
- Primary DI
- 00842092111796
- Version / Model
- 1300352
- Catalog Number
- 1300352
- 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
- bcce3a3d-909d-4eca-a243-ecc772c7147b
- Distribution End Date
- 2023-04-03
Device Description
Pin Screw 1.6mm Thread Cutter
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 |
|---|---|---|---|---|
| 45649 | Root canal post thread cutter | A hand-held, manually-operated, metal instrument used in dentistry to manually cut a thread into the root canal of a tooth so that the threads facilitate the insertion and anchoring of a root canal post of the pre-threaded type. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092111796 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]