FDA UDI
In Commercial Distribution
🇺🇸 United States
MULTIPEG
DI: D785MULTIPEGENG45600
·
Model: MULTIPEG FOR PENGUIN RFA FOR 4,5,6.0MM ENGAGE
·
OCO BIOMEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MULTIPEG
- Primary DI
- D785MULTIPEGENG45600
- Version / Model
- MULTIPEG FOR PENGUIN RFA FOR 4,5,6.0MM ENGAGE
- Catalog Number
- MULTIPEG ENG 4/5/6.0
- Company Name
- OCO BIOMEDICAL INC
- Labeler DUNS
- 094146123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-12
- Public Version
- 2
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- c6755187-bc92-4b48-a67b-8b516ca4bca0
Device Description
MULTIPEG FOR PENGUIN RFA FOR 4,5,6.0MM ENGAGE
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
- 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 |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63468 | Dental implant stability resonance frequency analysis peg | A small, screw-like device intended to be attached to a dental implant or abutment to measure the stability of the implant. It is used with a control unit (not included) which provides an electromagnetic pulsation to create a noninvasive vibrating force in the peg, and the subsequent degree of peg movement provides a measure of dental implant stability [typically referred to as resonance frequency analysis (RFA)]. This measurement can be repeated over time to help assess the progress of implant osseointegration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D785MULTIPEGENG45600 | HIBCC |