FDA UDI
In Commercial Distribution
🇺🇸 United States
DENTAL EQUIPMENTS
DI: 08059224151854
·
Model: CAP INSERT/EXTRAC.TOOL EQUATOR 50 u.
·
RHEIN 83 SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENTAL EQUIPMENTS
- Primary DI
- 08059224151854
- Version / Model
- CAP INSERT/EXTRAC.TOOL EQUATOR 50 u.
- Catalog Number
- ICEB-50
- Company Name
- RHEIN 83 SRL
- Labeler DUNS
- 439240722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-26
- Public Version
- 1
- Public Version Date
- 2021-02-03
- Public Version Status
- New
- Public Device Record Key
- 727d7394-f20e-4153-b2e0-b821d5bfae91
Device Description
Medical device to exctract and insert cap equator
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 |
|---|---|---|---|---|
| EJB | Handle, Instrument, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64627 | Dental implant holding endpiece | A device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft designed to be mounted onto the distal end of a manual screwdriver or slow-speed power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08059224151854 | GS1 |