FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Plus
DI: D838018OS2
·
Model: 018OS
·
Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
250
Basic Information
- Brand Name
- Premium Plus
- Primary DI
- D838018OS2
- Version / Model
- 018OS
- Company Name
- Premium Plus International Limited
- Labeler DUNS
- 668367758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2019-12-27
- Public Version
- 1
- Public Version Date
- 2020-01-06
- Public Version Status
- New
- Public Device Record Key
- 95905c8e-4ab6-4d8b-b5a0-431902f8280e
Device Description
SYRINGE TIPS
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 |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18033 | Surgical mist irrigation tip | A device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D838018OS8 | HIBCC | CASE | 10 | In Commercial Distribution | |
| Package | D838018OS6 | HIBCC | BOX | 6 | In Commercial Distribution | |
| Primary | D838018OS2 | HIBCC | ||||
| Unit of Use | D838018OS0 | HIBCC |