| Primary Device ID | J01810170 |
| NIH Device Record Key | 8f8b4319-f497-4400-9f05-b097c01e6312 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | J-Clasp |
| Version Model Number | 1017.2 |
| Company DUNS | 317683787 |
| Company Name | Scheu-Dental GmbH |
| Device Count | 100 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J01810170 [Unit of Use] |
| HIBCC | J01810171 [Primary] |
| HIBCC | J01810172 [Primary] |
| EHP | Clasp, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-27 |
| Device Publish Date | 2024-11-19 |
| J01810470 | J-Clasp Ø 1.1 mm |
| J01810190 | J-Clasp Ø 1.0 mm |
| J01810180 | J-Clasp Ø 0.9 mm |
| J01810170 | J-Clasp Ø 0.8 mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() J-CLASP 87842967 not registered Live/Pending |
Thomsen, Johannes 2018-03-21 |