| Primary Device ID | J01810210 |
| NIH Device Record Key | de553df3-31d6-46c5-8c09-a9704c5107a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | J-Clasp oblique |
| Version Model Number | 1021.2 |
| Company DUNS | 317683787 |
| Company Name | Scheu-Dental GmbH |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J01810210 [Unit of Use] |
| HIBCC | J01810211 [Primary] |
| HIBCC | J01810212 [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 |
| J01810480 | J-Clasp oblique Ø 1.1 mm, 10 pieces in pairs (5 left and 5 right) |
| J01810220 | J-Clasp oblique Ø 1.0 mm, 100 pieces in pairs (50 left and 50 right) |
| J01810210 | J-Clasp oblique Ø 0.9 mm, 100 pieces in pairs (50 left and 50 right) |
| J01810201 | J-Clasp oblique Ø 0.8 mm, 10 pieces in pairs (5 left and 5 right) |