FDA UDI
In Commercial Distribution
🇺🇸 United States
Stabilok
DI: 05060489370068
·
Model: Standard Blue
·
FAIRFAX MEDICAL PRODUCTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Stabilok
- Primary DI
- 05060489370068
- Version / Model
- Standard Blue
- Catalog Number
- SB
- Company Name
- FAIRFAX MEDICAL PRODUCTS LIMITED
- Labeler DUNS
- 227221793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-04-16
- Public Version
- 1
- Public Version Date
- 2023-04-24
- Public Version Status
- New
- Public Device Record Key
- c1b22690-281f-4467-ab5d-ab8d82423866
Device Description
Intended use to anchor a dentine pin in tooth dentine prior to building up the tooth. 20 single use pins + 1 reusable drill
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | 872.3740 | 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 | 05060489370204 | GS1 | ||||
| Primary | 05060489370068 | GS1 |
Customer Contacts
- Phone
- +442089476464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.60 | Millimeter |