FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Plus
DI: D83817802
·
Model: 178-0
·
Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Premium Plus
- Primary DI
- D83817802
- Version / Model
- 178-0
- Company Name
- Premium Plus International Limited
- Labeler DUNS
- 668367758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-01-08
- Public Version
- 1
- Public Version Date
- 2020-01-16
- Public Version Status
- New
- Public Device Record Key
- 7a7de515-0a59-4e1e-86b0-273455eabe1f
Device Description
Protective Paper Covers
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 |
|---|---|---|---|---|
| 17102 | X-ray film storage envelope | A thick paper envelope configured to form a flat container/holder specifically designed for the storage and transport of images recorded on x-ray film. It is usually of a size to contain sheet film (35 x 43 cm), but is also available in sizes designed to accommodate specialized x-ray film formats, e.g., those used in chiropractic, paediatric or mammography imaging applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D83817802 | HIBCC | ||||
| Unit of Use | D83817800 | HIBCC |