| Primary Device ID | 08717228442377 |
| NIH Device Record Key | 3cbc1755-42c9-4a6d-8d3e-787d760b4d96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Care Stream Dental |
| Version Model Number | BDA32 |
| Catalog Number | BDA32 |
| Company DUNS | 413491023 |
| Company Name | DuPhaMed B.V. |
| Device Count | 150 |
| DM Exempt | false |
| 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 |
|---|---|
| GS1 | 08717228440557 [Primary] |
| GS1 | 08717228442377 [Unit of Use] |
| EGZ | Holder, Film, X-Ray |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-01 |
| Device Publish Date | 2023-11-23 |
| 08717228442346 | Hygienic sheaths CS 7600 for phosphor plate size 4 |
| 08717228442339 | 7600 #3 |
| 08717228442322 | Hygienic sheaths CS 7600 for phosphor plate size 2 |
| 08717228442315 | Hygienic sheaths CS 7600 for phosphor plate size 1 |
| 08717228442148 | Hygienic sheaths CS 7600 for phosphor plate size 0 |
| 08717228442131 | Hygienic sheaths CS 7200 for phosphor plate size 2 |
| 08717228442124 | Hygienic sheaths CS 7200 for phosphor plate size 1 |
| 08717228442117 | Hygienic sheaths CS 7200 for phosphor plate size 0 |
| 08717228442438 | Hygienic Sensor Sleeves # 0 |
| 08717228442421 | Hygienic Sensor Sleeves Size 2 |
| 08717228442391 | Hygienic Sensor Sleeves # 1 |
| 08717228442384 | Hygienic sheaths for biteblock 3D |
| 08717228442377 | Hygienic sheaths for biteblock (small) |
| 08717228440526 | Ear sleeve Ceph, single-use hygienic covers/sleeves for ear rods. |