FDA UDI
In Commercial Distribution
🇺🇸 United States
EDENTA
DI: E312PFDS21
·
Model: PFDS2
·
EDENTA ETABLISSEMENT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- EDENTA
- Primary DI
- E312PFDS21
- Version / Model
- PFDS2
- Company Name
- EDENTA ETABLISSEMENT
- Labeler DUNS
- 448002915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-02-03
- Public Version
- 1
- Public Version Date
- 2022-02-11
- Public Version Status
- New
- Public Device Record Key
- 91cf35f2-8fb0-4eaf-9570-b9341def3d20
Device Description
Diamonstrip perforated
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DZP | INSTRUMENT, DIAMOND, DENTAL | Dental | 872.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63358 | Dental abrasive strip, reusable | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | E312PFDS2101 | HIBCC | ||||
| Primary | E312PFDS21 | HIBCC |