FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832PS8501
·
Model: PS850
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
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Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832PS8501
- Version / Model
- PS850
- Catalog Number
- PS850
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2022-08-30
- Public Version
- 1
- Public Version Date
- 2022-09-07
- Public Version Status
- New
- Public Device Record Key
- 17b6adde-fc18-49fa-99fa-ff7103c7c563
Device Description
Biohazard Bags, Stick-On, Red, 9" X 10"
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 |
|---|---|---|---|---|
| 12223 | Bucket liner | A device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D832PS8502 | HIBCC | Case | 8 | In Commercial Distribution | |
| Primary | D832PS8501 | HIBCC | ||||
| Unit of Use | D832PS8500 | HIBCC |