FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Plus
DI: D838140S2
·
Model: 140S
·
Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
500
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Basic Information
- Brand Name
- Premium Plus
- Primary DI
- D838140S2
- Version / Model
- 140S
- Company Name
- Premium Plus International Limited
- Labeler DUNS
- 668367758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2017-07-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b3980477-de26-4aa1-a9eb-734eeaeec467
Device Description
Disposable Barrier Sleeves
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61049 | Instrument/equipment drape, single-use, non-sterile | A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D838140S8 | HIBCC | case | 4 | In Commercial Distribution | |
| Package | D838140S6 | HIBCC | carton | 10 | In Commercial Distribution | |
| Primary | D838140S2 | HIBCC | ||||
| Unit of Use | D838140S0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163447 | 000 |