FDA UDI
Not in Commercial Distribution
🇺🇸 United States
InnerView® System Disposable Tips
DI: 10860011518324
·
Model: INV-3000
·
Perimetrics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- InnerView® System Disposable Tips
- Primary DI
- 10860011518324
- Version / Model
- INV-3000
- Catalog Number
- INV-3000
- Company Name
- Perimetrics, Inc.
- Labeler DUNS
- 036802075
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2025-03-05
- Public Version
- 4
- Public Version Date
- 2025-09-01
- Public Version Status
- Update
- Public Device Record Key
- 9730a2cd-1810-4f50-8c3e-d37fc9ef3089
- Distribution End Date
- 2025-08-31
Device Description
Non-sterile, single-use disposable tips intended for use with InnerView System Handpiece.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 67339 | Dental stability percussive analysis handpiece cover | A device in the form of a thin lid intended to be used as a physical barrier between the patient and the tip of a dental stability percussive analysis handpiece to prevent cross-contamination between patients. It may incorporate a non-powered microchip with a unique security code intended to be read by the handpiece to verify it has not been reused. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10860011518324 | GS1 | ||||
| Unit of Use | 00860011518327 | GS1 |
Customer Contacts
- Phone
- 1-888-325-7218
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232657 | 000 |