FDA UDI
In Commercial Distribution
🇺🇸 United States
TRANSPARENT ODUS UNIVERSAL STRIPS STRAIGHT, 10 mm
DI: 07640159161868
·
Model: 43703d
·
Produits dentaires S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRANSPARENT ODUS UNIVERSAL STRIPS STRAIGHT, 10 mm
- Primary DI
- 07640159161868
- Version / Model
- 43703d
- Company Name
- Produits dentaires S.A.
- Labeler DUNS
- 480420090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-28
- Public Version
- 1
- Public Version Date
- 2022-07-06
- Public Version Status
- New
- Public Device Record Key
- d9dbe44d-66be-4c3a-8869-1c490594b5e9
Device Description
Transparent strips are matrices which help contour restorative materials to match natural dentition (generally light-cured composite on anterior tooth). Transparent strips are made of Biaxially-oriented Polyethylene terephthalate (Bo-PET) films. The products are used in the dentistry field. Pack of 50
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
- Yes
- 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 |
|---|---|---|---|---|
| JEP | Retainer, Matrix | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16195 | Dental matrix band, reusable | A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640159161868 | GS1 |
Customer Contacts
- Phone
- +41219212631
- [email protected]