FDA UDI
In Commercial Distribution
🇺🇸 United States
Preat
DI: 00842092181553
·
Model: 1500610
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Preat
- Primary DI
- 00842092181553
- Version / Model
- 1500610
- Catalog Number
- 1500610
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-21
- Public Version
- 2
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- f3d8f270-d338-4d31-9158-0724429d7543
Device Description
O-Ring Mini Implant Servicing Kit Kit contains 2 O-Ring Black Rings #2 Micro Single 1 O-Ring Yellow Processing #2 Micro Single 1 O-Ring Closed Metal Housing #2 MH-2 1 O-Ring Mini Implant Analog 1 O-Ring Mini Implant Impression Coping
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
- 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 |
|---|---|---|---|---|
| 38603 | Resilient dental precision attachment | A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092181553 | GS1 | ||||
| Previous | 00842092170144 | GS1 |
Customer Contacts
- Phone
- +1 (800) 232-7732
- [email protected]