FDA UDI
In Commercial Distribution
🇺🇸 United States
INVASIVE ACCESSORIES AND INSTRUMENTS
DI: 08059224154985
·
Model: BROKEN SCREW EXT.KIT ZIMMER ø 3,75 - 4,5
·
RHEIN 83 SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- INVASIVE ACCESSORIES AND INSTRUMENTS
- Primary DI
- 08059224154985
- Version / Model
- BROKEN SCREW EXT.KIT ZIMMER ø 3,75 - 4,5
- Catalog Number
- 680CV-IQ
- Company Name
- RHEIN 83 SRL
- Labeler DUNS
- 439240722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-20
- Public Version
- 1
- Public Version Date
- 2021-07-28
- Public Version Status
- New
- Public Device Record Key
- f7307167-5c56-428a-b3e3-618f2adb3e6b
Device Description
BROKEN SCREW EXTRACTOR KIT is a system that allow to remove broken thread into a fixture when it is not cemented or damaged attempting to remove it in other way.
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 |
|---|---|---|---|---|
| DZA | Drill, Dental, Intraoral | Dental | 872.4130 | 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 | 08059224154985 | GS1 | ||||
| Previous | D821680CVIQ0 | HIBCC |