| Primary Device ID | D8382288W8 |
| NIH Device Record Key | 654f3573-bd4f-43a0-a3f7-994ba141066f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium Plus |
| Version Model Number | 2288W |
| Company DUNS | 668367758 |
| Company Name | Premium Plus International Limited |
| Device Count | 50 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8382288W0 [Unit of Use] |
| HIBCC | D8382288W2 [Primary] |
| HIBCC | D8382288W8 [Package] Contains: D8382288W2 Package: CASE [20 Units] In Commercial Distribution |
| LYU | Accessory, Surgical Apparel |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2019-12-26 |
| 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 |