FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832PBA273020
·
Model: PBA2730-2
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832PBA273020
- Version / Model
- PBA2730-2
- Catalog Number
- PBA2730-2
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-25
- Public Version
- 1
- Public Version Date
- 2022-04-04
- Public Version Status
- New
- Public Device Record Key
- c3749698-7f5f-485f-9e75-52efbc059e11
Device Description
Patient Barrier Apron, Waist Length, 27" X 30", Polyester, Blue
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 31044 | Bib/apron, adult, reusable | A garment that is worn over the front of the body of an adult (e.g., a person with a disability or a geriatric) to protect their clothing and body from becoming soiled typically when feeding or being fed or from dribbling or from therapeutic social activities, e.g., arts and crafts. It can be made of textiles and/or plastic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D832PBA273020 | HIBCC |