FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832PS2021
·
Model: PS202
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832PS2021
- Version / Model
- PS202
- Catalog Number
- PS202
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2022-06-16
- Public Version
- 1
- Public Version Date
- 2022-06-24
- Public Version Status
- New
- Public Device Record Key
- acf43b37-cee1-4a62-8d2e-8a813d0fac6a
Device Description
Size A Tray Cover w/ Lock Top, 11 5/8" X 14 1/2"
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 |
|---|---|---|---|---|
| 64367 | Instrument tray cover, single-use | A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D832PS2022 | HIBCC | Case | 6 | In Commercial Distribution | |
| Primary | D832PS2021 | HIBCC | ||||
| Unit of Use | D832PS2020 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201604 | 000 |