Premium Plus
GUDID D8381098
Disposable Barrier Sleeves
Premium Plus International Limited
Instrument/equipment drape, single-use, non-sterile| Primary Device ID | D8381098 |
| NIH Device Record Key | be5d441e-82af-427f-8cbc-ce6864114834 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium Plus |
| Version Model Number | 109 |
| Company DUNS | 668367758 |
| Company Name | Premium Plus International Limited |
| Device Count | 250 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8381090 [Unit of Use] |
| HIBCC | D8381092 [Primary] |
| HIBCC | D8381098 [Package] Contains: D8381092 Package: case [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163447
FDA Product Code
| PEM | Dental Barriers And Sleeves |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-07-07 |
On-Brand Devices [Premium Plus]
| D838C022 | Dental curing light |
| D8388008C8 | Disposable Barrier Film |
| D8388008B8 | Disposable Barrier Film |
| D83860158 | Self Sealing Sterilization Pouches |
| D83860118 | Self Sealing Sterilization Pouches |
| D83860098 | Self Sealing Sterilization Pouches |
| D83860078 | Self Sealing Sterilization Pouches |
| D83860052 | Self Sealing Sterilization Pouches |
| D83860038 | Self Sealing Sterilization Pouches |
| D83860018 | Self Sealing Sterilization Pouches |
| D83819928 | Disposable Barrier Sleeves |
| D83819918 | Disposable Barrier Sleeves |
| D83819908 | Disposable Barrier Sleeves |
| D8381982B8 | Disposable Barrier Sleeves |
| D83819828 | Disposable Barrier Sleeves |
| D83819818 | Disposable Barrier Sleeves |
| D83819808 | Disposable Barrier Sleeves |
| D8381908 | Disposable Barrier Sleeves |
| D83818928 | Disposable Barrier Sleeves |
| D83818918 | Disposable Barrier Sleeves |
| D83818908 | Disposable Barrier Sleeves |
| D83818848 | Disposable Barrier Sleeves |
| D83818838 | Disposable Barrier Sleeves |
| D8381882B8 | Disposable Barrier Sleeves |
| D83818828 | Disposable Barrier Sleeves |
| D83818818 | Disposable Barrier Sleeves |
| D83818808 | Disposable Barrier Sleeves |
| D83818328 | Disposable Barrier Sleeves |
| D83818318 | Disposable Barrier Sleeves |
| D8381588 | Disposable Barrier Sleeves |
| D8381458 | Disposable Barrier Sleeves |
| D838140XS8 | Disposable Barrier Sleeves |
| D838140S8 | Disposable Barrier Sleeves |
| D838140M8 | Disposable Barrier Sleeves |
| D838140L8 | Disposable Barrier Sleeves |
| D8381388 | Disposable Barrier Sleeves |
| D8381368 | Disposable Barrier Sleeves |
| D838135S8 | Disposable Barrier Sleeves |
| D838135L8 | Disposable Barrier Sleeves |
| D8381338 | Disposable Barrier Sleeves |
| D8381298 | Disposable Barrier Sleeves |
| D8381288 | Disposable Barrier Sleeves |
| D838125SS8 | Disposable Intraoral Camera / Curing Light Sleeves |
| D8381258 | Disposable Barrier Sleeves |
| D838123XL8 | Disposable Barrier Sleeves |
| D838123SS8 | Disposable Curing Light Sleeves |
| D838123S8 | Disposable Curing Light Sleeves |
| D838123L8 | Disposable Barrier Sleeves |
| D8381218 | Disposable Barrier Sleeves |
| D8381198 | Disposable Barrier Sleeves |
Trademark Results [Premium Plus]
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