FDA UDI
In Commercial Distribution
🇺🇸 United States
Neoss SmartPeg Mount
DI: 09010522002469
·
Model: Neoss SmartPeg Mount
·
Osstell AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neoss SmartPeg Mount
- Primary DI
- 09010522002469
- Version / Model
- Neoss SmartPeg Mount
- Catalog Number
- 91075
- Company Name
- Osstell AB
- Labeler DUNS
- 633171269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-06
- Public Version
- 1
- Public Version Date
- 2023-12-14
- Public Version Status
- New
- Public Device Record Key
- eb91c67a-b486-48b9-a9ad-1156d0dae526
Device Description
SmartPeg Mount
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63467 | Dental implant stability measurement control unit | An electrically-powered device designed to measure the stability of a dental implant by creating a noninvasive vibrational force and subsequently detecting the amount of movement in the implant. It is used with a disposable peg (not included) inserted into the implant or abutment, and consists of electronics to create an electromagnetic pulsation, monitor, controls and probe. This measurement can be repeated over time to assess the progress of implant osseointegration. It may be supplied with accessories such as mounts and test pegs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09010522002469 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181888 | 000 |