Premium Plus
- Primary DI
- D1251282
- Brand
- Premium Plus
- Company
- Premium Plus (Dongguan) Limited
- Model
- 128
- Device description
- Disposable Barrier Sleeves
- Published
- 2026-05-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| PEM | Dental Barriers And Sleeves |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K220662 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D1251286 | Package | HIBCC | 50 | In Commercial Distribution |
| D1251288 | Package | HIBCC | 4 | In Commercial Distribution |
| D1251282 | Primary | HIBCC | 0 | |
| D1251280 | Unit of Use | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Digital imaging cassette | A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device. |
Regulatory Flags
- DUNS number
- 541637603
- Device count
- 200
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D125100B2 | Premium Plus | 100B | 2026-05-22 | |
| D125100C2 | Premium Plus | 100C | 2026-05-22 | |
| D1251012 | Premium Plus | 101 | 2026-05-22 | |
| D1251022 | Premium Plus | 102 | 2026-05-22 | |
| D1251032 | Premium Plus | 103 | 2026-05-22 | |
| D125104L2 | Premium Plus | 104L | 2026-05-22 | |
| D125104S2 | Premium Plus | 104S | 2026-05-22 | |
| D1251062 | Premium Plus | 106 | 2026-05-22 | |
| D1251072 | Premium Plus | 107 | 2026-05-22 | |
| D1251082 | Premium Plus | 108 | 2026-05-22 | |
| D1251092 | Premium Plus | 109 | 2026-05-22 | |
| D1251112 | Premium Plus | 111 | 2026-05-22 | |
| D1251122 | Premium Plus | 112 | 2026-05-22 | |
| D1251132 | Premium Plus | 113 | 2026-05-22 | |
| D1251142 | Premium Plus | 114 | 2026-05-22 | |
| D1251182 | Premium Plus | 118 | 2026-05-22 | |
| D1251192 | Premium Plus | 119 | 2026-05-22 | |
| D125123L2 | Premium Plus | 123L | 2026-05-22 | |
| D125123M2 | Premium Plus | 123M | 2026-05-22 | |
| D125123S2 | Premium Plus | 123S | 2026-05-22 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| D125100B2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125100C2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251012 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251022 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251032 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125104L2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125104S2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251062 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251072 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251082 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251092 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251112 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251122 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251132 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251142 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251182 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251192 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125123L2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125123M2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125123S2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125123SS2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125123XL2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251252 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125125SS2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251292 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125133L2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125133S2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125135L2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D125135S2 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |
| D1251362 | Premium Plus | Premium Plus (Dongguan) Limited | PEM | 2026-05-22 |