FDA UDI
In Commercial Distribution
🇺🇸 United States
Preat
DI: 00842092172544
·
Model: 0109003
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
13
Basic Information
- Brand Name
- Preat
- Primary DI
- 00842092172544
- Version / Model
- 0109003
- Catalog Number
- 0109003
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 13
- 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
- 58d60c63-9700-4539-b0df-a178ca10b607
Device Description
Perma Ret Wire Refill
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 35868 | Dental restoration retention pin | A device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00842092166390 | GS1 | ||||
| Primary | 00842092172544 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]