| Primary Device ID | D800ZRAC09210 |
| NIH Device Record Key | 033f8f7b-8710-420d-ae11-fee91a60664f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ICE Plus 98H18 with step |
| Version Model Number | ZRAC0921 |
| Company DUNS | 564251911 |
| Company Name | ZIRKONZAHN SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | D800ZRAC09210 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-11 |
| Device Publish Date | 2025-02-03 |
| D800ZRAC09010 - ICE Plus 98H10 | 2025-02-11 Content: 1 piece Height: 10 mm |
| D800ZRAC09110 - ICE Plus 98H14 with step | 2025-02-11 Content: 1 piece Height: 14 mm |
| D800ZRAC09210 - ICE Plus 98H18 with step | 2025-02-11 |
| D800ZRAC09210 - ICE Plus 98H18 with step | 2025-02-11 |
| D800ZRAC09310 - ICE Plus 98H20 with step | 2025-02-11 ICE Plus 98H20 with step |
| D800ZRAC09410 - ICE Plus 98H12 with step | 2025-02-11 Content: 1 piece Height: 12 mm |
| D800ZRAC09510 - ICE Plus 98H22 with step | 2025-02-11 Content: 1 piece Height: 22 mm |
| D800ZRAC09620 - ICE Plus 98H16 with step | 2025-02-11 Content: 1 piece Height: 16 mm |
| D800ZRAC09710 - ICE Plus 98H25 with step | 2025-02-11 Content: 1 piece Height: 25 mm |