FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832RMML0
·
Model: RM-ML
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832RMML0
- Version / Model
- RM-ML
- Catalog Number
- RM-ML
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-27
- Public Version
- 1
- Public Version Date
- 2022-02-04
- Public Version Status
- New
- Public Device Record Key
- b35b9441-5521-4338-bcfe-e607daab137c
Device Description
45' Mylar Roll Matrix Dispenser, 9 1/2mm (3/8") X 0.05mm (0.002")
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 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 | D832RMML0 | HIBCC |