FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832PSDEMI1
·
Model: PS-DEMI
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
400
Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832PSDEMI1
- Version / Model
- PS-DEMI
- Catalog Number
- PS-DEMI
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2022-07-19
- Public Version
- 1
- Public Version Date
- 2022-07-27
- Public Version Status
- New
- Public Device Record Key
- 1379b1c9-d909-4d56-9ff5-fbb7932065ff
Device Description
Curing Light Cover for Demi
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
- 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 |
|---|---|---|---|---|
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D832PSDEMI2 | HIBCC | Case | 20 | In Commercial Distribution | |
| Primary | D832PSDEMI1 | HIBCC | ||||
| Unit of Use | D832PSDEMI0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201604 | 000 |