FDA UDI
In Commercial Distribution
🇺🇸 United States
InnerView® System Base Station
DI: 00860011518310
·
Model: INV-2000
·
Perimetrics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InnerView® System Base Station
- Primary DI
- 00860011518310
- Version / Model
- INV-2000
- Catalog Number
- INV-2000
- Company Name
- Perimetrics, Inc.
- Labeler DUNS
- 036802075
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-05
- Public Version
- 1
- Public Version Date
- 2025-03-13
- Public Version Status
- New
- Public Device Record Key
- 591ab583-4112-46a4-8de5-ab936ea26426
Device Description
InnerView System Base Station
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 67338 | Dental stability percussive analysis handpiece | A hand-held, electrically-powered, dental device which consists of a handpiece with controls and a moving tip intended to provide percussion (tapping) to the tooth/teeth and/or dental implant(s) to assess the stability of the tooth, implant and/or periodontium (e.g., for movability or presence of fractures/gap defects) via the acquired force-time measurements; it is not intended for attachment to a dental implant (i.e., is not intended for resonance frequency analysis). It is intended to transmit the measurements to an off-the-shelf computerized device with a dedicated software (not included) for processing and display. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011518310 | GS1 |
Customer Contacts
- Phone
- 1-888-325-7218
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232657 | 000 |