FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07630031758804
·
Model: Edentulous Abutments
·
Institut Straumann AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- NA
- Primary DI
- 07630031758804
- Version / Model
- Edentulous Abutments
- Catalog Number
- 2102.0008-OPT
- Company Name
- Institut Straumann AG
- Labeler DUNS
- 483599259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2022-12-02
- Public Version
- 2
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- dda580de-ccd2-4dbf-a5f4-9b69e4e1c931
Device Description
Optiloc® Retention Insert Black - Ultra-Strong, PEEK
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 38580 | Sliding dental precision attachment | A device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07630031772305 | GS1 | ||||
| Primary | 07630031758804 | GS1 |
Customer Contacts
- Phone
- +1(800)448-8168
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight