| Primary Device ID | 08717228442803 |
| NIH Device Record Key | f6cf99a7-1451-475c-84a2-9ff1be68285f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cefla |
| Version Model Number | QR32DH58 |
| Catalog Number | 97901523 |
| Company DUNS | 413491023 |
| Company Name | DuPhaMed B.V. |
| Device Count | 50 |
| 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 | 08717228440489 [Primary] |
| GS1 | 08717228442803 [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 |
| 08717228442803 | Short band for headrest 58 cm in length |
| 08717228442797 | Short band for headrest 52 cm in length |
| 08717228441790 | Clip for Phosphor Plate Holder |
| 08717228442780 | Foam Bites, Cushion inserts for biteblock |
| 08717228440441 | Phosphor Plate Holder Introduction Pack, content: 2x bitewing - UDI 08717228440243 2x posterior |
| 08717228442773 | Hygienic Sheaths for sensor Size 2 |
| 08717228442766 | Hygienic Sheaths for sensor Size 1 |
| 08717228442759 | Hygienic Sheaths for biteblock |
| 08717228442742 | Hygienic Phosphor Sleeves multi sizes |
| 08717228442735 | Hygienic Phosphor Sleeves Size 3 |
| 08717228442728 | Hygienic Phosphor Sleeves Size 2 |
| 08717228442711 | Hygienic Phosphor Sleeves Size 1 |
| 08717228442636 | Hygienic Phosphor Sleeves Size 0 |
| 08717228440359 | X-Ray sensor holder Refill Pack Endo Size 2, Content: 3x endo Upper Left / Lower Right - UDI 087 |
| 08717228440342 | X-Ray sensor holder Refill Pack Endo Size 1, Content: 3x endo Upper Left / Lower Right - UDI 08 |
| 08717228440335 | X-Ray sensor holder Refill Pack Periapical Size 2, Content: 5x periapical Upper Left / Lower Ri |
| 08717228440328 | X-Ray sensor holder Refill Pack Periapical Size 1, Content: 5x periapical Upper Left / Lower Ri |
| 08717228440311 | X-Ray sensor holder Refill Pack Posterior Size 2, Content: 5x posterior Upper Left / Lower Right |
| 08717228440304 | X-Ray sensor holder Refill Pack Posterior Size 1, Content: 5x posterior Upper Left / Lower Righ |
| 08717228441042 | X-Ray sensor holder Refill Pack Bitewing Size 2 |
| 08717228441035 | X-Ray sensor holder Refill Pack Bitewing Size 1 |
| 08717228440274 | X-Ray sensor holder Introduction Pack Size 2, content: 1x bitewing - UDI 08717228441042 1x post |
| 08717228440267 | X-Ray sensor holder Introduction Pack Size 1, content: 1x bitewing - UDI 08717228441035 1x poste |
| 08717228441028 | Positioning rings |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CEFLA 85688293 4371060 Live/Registered |
CEFLA S.C. 2012-07-27 |
![]() CEFLA 76388691 2774711 Dead/Cancelled |
CEFLA SOC. COOP. a r.l. 2002-03-26 |