FDA UDI
In Commercial Distribution
🇺🇸 United States
OVC3 One Visit Crown
DI: 09421031795573
·
Model: OVC3 McDonald Matrix Band - Premolar Accessories Pack
·
RHONDIUM LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OVC3 One Visit Crown
- Primary DI
- 09421031795573
- Version / Model
- OVC3 McDonald Matrix Band - Premolar Accessories Pack
- Catalog Number
- 9421031795573
- Company Name
- RHONDIUM LIMITED
- Labeler DUNS
- 595078345
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-28
- Public Version
- 2
- Public Version Date
- 2019-03-14
- Public Version Status
- Update
- Public Device Record Key
- 5c44fb83-7914-41d8-9b33-ad515982e4cc
Device Description
Packages contain x6 matrix bands for upper premolars 14.15 S (small), 14.15 M (medium), 14.15 L (large), 24.25 S (small), 24.25 M (medium), 24.25 L (large), x6 matrix bands for lower premolars 34.35 S (small), 34.35 M (medium), 34.35 L (large), 44.45 S (small), 44.45 M (medium), 44.45 L (large), x 16 stretch wedges
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38786 | Dental matrix band, single-use | A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421031795573 | GS1 |
Customer Contacts
- Phone
- 1-800-875-6246
- [email protected]