FDA UDI
In Commercial Distribution
🇺🇸 United States
SeptoWedges Refill: 100 wooden wedges n°4-violet
DI: 07897990329111
·
Model: 01C4024
·
SEPTODONT SAS SPECIALITES SEPTODONT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeptoWedges Refill: 100 wooden wedges n°4-violet
- Primary DI
- 07897990329111
- Version / Model
- 01C4024
- Catalog Number
- 01C4024
- Company Name
- SEPTODONT SAS SPECIALITES SEPTODONT
- Labeler DUNS
- 275273795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-19
- Public Version
- 1
- Public Version Date
- 2022-12-27
- Public Version Status
- New
- Public Device Record Key
- 248147e0-fbf6-442c-ad74-73af73fb7f25
Device Description
wood wedges
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
- No
- 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 | 07897990329111 | GS1 |