FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Plus
DI: D8382223W2
·
Model: 2223W
·
Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1200
Basic Information
- Brand Name
- Premium Plus
- Primary DI
- D8382223W2
- Version / Model
- 2223W
- Company Name
- Premium Plus International Limited
- Labeler DUNS
- 668367758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1200
- Record Status
- Published
- Publish Date
- 2019-12-26
- Public Version
- 1
- Public Version Date
- 2020-01-03
- Public Version Status
- New
- Public Device Record Key
- 2862b1ca-35f6-4d95-8043-63c18556ecde
Device Description
TRAY COVER PAPERS
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KHR | Absorber, Saliva, Paper | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33531 | Saliva absorbent | A non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8382223W2 | HIBCC | ||||
| Unit of Use | D8382223W0 | HIBCC |