FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent UltraProof Earloop Mask
DI: D832MK32
·
Model: MK2
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Plasdent UltraProof Earloop Mask
- Primary DI
- D832MK32
- Version / Model
- MK2
- Catalog Number
- MK3-2
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-21
- Public Version
- 5
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 51c87726-86e2-4e5e-a90b-a346fccd65be
Device Description
DuralProof(TM) Earloop Face Mask - Blue (40pcs/box)
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 |
|---|---|---|---|---|
| FXX | Mask, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57792 | Surgical/medical respirator, antimicrobial | A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is designed to create an airtight seal against the user’s face and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D832MK325 | HIBCC | case | 800 | In Commercial Distribution | |
| Primary | D832MK32 | HIBCC | ||||
| Package | D832MK321 | HIBCC | box | 40 | In Commercial Distribution | |
| Package | D832MK322 | HIBCC | Case | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133070 | 000 |