| Primary Device ID | J01810230 |
| NIH Device Record Key | f61ac9f1-c34e-4762-8716-d59cef639e33 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JM-Clasp |
| Version Model Number | 1023.1 |
| Company DUNS | 317683787 |
| Company Name | Scheu-Dental GmbH |
| Device Count | 10 |
| 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 | J01810230 [Unit of Use] |
| HIBCC | J01810231 [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 |
| J01810170 - J-Clasp | 2024-11-27 J-Clasp Ø 0.8 mm |
| J01810180 - J-Clasp | 2024-11-27 J-Clasp Ø 0.9 mm |
| J01810190 - J-Clasp | 2024-11-27 J-Clasp Ø 1.0 mm |
| J01810201 - J-Clasp oblique | 2024-11-27 J-Clasp oblique Ø 0.8 mm, 10 pieces in pairs (5 left and 5 right) |
| J01810210 - J-Clasp oblique | 2024-11-27 J-Clasp oblique Ø 0.9 mm, 100 pieces in pairs (50 left and 50 right) |
| J01810220 - J-Clasp oblique | 2024-11-27 J-Clasp oblique Ø 1.0 mm, 100 pieces in pairs (50 left and 50 right) |
| J01810230 - JM-Clasp | 2024-11-27JM-Clasp Ø 1.2 mm |
| J01810230 - JM-Clasp | 2024-11-27 JM-Clasp Ø 1.2 mm |
| J01810260 - T-Clasp | 2024-11-27 T-Clasp Ø 0.9 mm |