FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OVC Hybrid
DI: 09421031794101
·
Model: OVC3 Hybrid FDI 34.35 XL : USA 20-21 XL A2
·
RHONDIUM LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OVC Hybrid
- Primary DI
- 09421031794101
- Version / Model
- OVC3 Hybrid FDI 34.35 XL : USA 20-21 XL A2
- Catalog Number
- 9421031794101
- Company Name
- RHONDIUM LIMITED
- Labeler DUNS
- 595078345
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-22
- Public Version
- 5
- Public Version Date
- 2019-03-28
- Public Version Status
- Update
- Public Device Record Key
- 555b80b7-c458-44ec-95df-cbff8dee4d5c
- Distribution End Date
- 2019-03-15
Device Description
Package contains an OVC Hybrid in shade A2 for tooth number FDI 34.35 XL : USA 20-21 XL (Extra-Large) , 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band, 1 x Hex Stick and 1 x OVC Replica.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61718 | Preformed dental crown, permanent | A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421031794101 | GS1 |
Customer Contacts
- Phone
- 1-800-875-6246
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Extra-Large |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 25 Degrees Celsius