| Primary Device ID | D915WHW2 |
| NIH Device Record Key | 5c16d6da-dbef-42c9-8c34-afbf91bf445c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plastcare |
| Version Model Number | WHW |
| Company DUNS | 079299604 |
| Company Name | Plastcare USA |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | D915WHW0 [Unit of Use] |
| HIBCC | D915WHW1 [Primary] |
| HIBCC | D915WHW2 [Package] Contains: D915WHW1 Package: [10 Units] In Commercial Distribution |
| DYN | Mouthpiece, Saliva Ejector |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-11 |
| Device Publish Date | 2020-05-01 |
| D915RIT75141 | (7 1/2" x 14") Sterilization Pouches |
| D915RIT52111 | (2 1/4" x 10") Sterilization Pouches |
| D915RIT43122 | (4 1/4" x 12") Sterilization Pouches |
| D915RIT35651 | ( 3 1/2" x 5 1/4") Sterilization Pouches |
| D915RIT35101 | (3 1/2" X 10") Sterilization Pouches |
| D915RIT33122 | (3 1/4" x 12") Sterilization Pouches |
| D915RIT27101 | (2 3/4" x 9") Sterilization Pouches |
| D915RIT23902 | (2 1/4" x 9'") Sterilization Pouches |
| D915RIT23502 | (2 1/4" x 5") Sterilization Pouches |
| D915RIT23372 | (2 1/4" x 3 3/4") Sterilization Pouches |
| D915RIT12192 | (12" X 19") Sterilization Pouches |
| D915RIT10161 | (10" x 16") Sterilization Pouches |
| D915RIT22042 | Gauze Non Woven Sponges 2 x 2 Inch. |
| D915S12CC2 | Utility syringe curved 12cc |
| D915RIT73122 | Dental Impression Bite Tray Anterior (Purple) |
| D915RIT73112 | Dental Impression Bite Tray Full Arch (Pink) |
| D915HVE012 | Vented Evacuation Tips White Color |
| D915E10022 | Surgical Aspirator Tips White Medium Vented 1/8" Diam |
| D915E10032 | Surgical Aspirator Tips Green Large Vented 1/4" Diam |
| D915RITG30P2 | Isolation Gown with Knit Cuffs - Pink |
| D915RITG30B2 | Isolation Gown with Knit Cuffs - Blue |
| D915RIT73152 | Dental Impression Bite Tray Sideless (White) |
| D915RIT73132 | Dental Impression Bite Tray Quadrant (Yellow) |
| D915E10012 | Surgical Aspirator Tips Blue Small Vented 1/16" Diam |
| D915RIT50302 | 5oz Disposable Plastic Dental Cup Lavender |
| D915RIT44042 | Gauze Non Woven Sponges 4 x 4 Inch. |
| D915RIT33042 | Gauze Non Woven Sponges 3 x 3 Inch. |
| D915CLB2 | Saliva Ejector Clear with Blue Tip |
| D915RIT50102 | 5oz Disposable Plastic Dental Cup Blue |
| D915RIT50252 | 5oz Disposable Plastic Dental Cup White |
| D915RIT50202 | 5oz Disposable Plastic Dental Cup Green |
| D915RIT50152 | 5oz Disposable Plastic Dental Cup Pink |
| D915WHW2 | Saliva Ejector White with White Tip |