| Primary Device ID | 07290018434024 |
| NIH Device Record Key | b9b7369b-f943-4ee2-8379-e967bff70a81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alef Spiral Implant |
| Version Model Number | 3.5 x 11.5 |
| Catalog Number | AL3511 |
| Company DUNS | 531825934 |
| Company Name | MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 |
|---|---|
| GS1 | 07290018434024 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-31 |
| Device Publish Date | 2024-01-23 |
| 07290018434260 | 6.0 x 13 |
| 07290018434253 | 6.0 x 11.5 |
| 07290018434246 | 6.0 x 10 |
| 07290018434239 | 6.0 x 8 |
| 07290018434215 | 5.0 x 16 |
| 07290018434208 | 5.0 x 13 |
| 07290018434192 | 5.0 x 11.5 |
| 07290018434185 | 5.0 x 10 |
| 07290018434178 | 5.0 x 8 |
| 07290018434154 | 4.2 x 16 |
| 07290018434147 | 4.2 x 13 |
| 07290018434130 | 4.2 x 11.5 |
| 07290018434123 | 4.2 x 10 |
| 07290018434116 | 4.2 x 8 |
| 07290018434093 | 3.75 x 16 |
| 07290018434086 | 3.75 x 13 |
| 07290018434079 | 3.75 x 11.5 |
| 07290018434062 | 3.75 x 10 |
| 07290018434055 | 3.75 x 8 |
| 07290018434048 | 3.5 x 16 |
| 07290018434031 | 3.5 x 13 |
| 07290018434024 | 3.5 x 11.5 |
| 07290018434017 | 3.5 x 10 |
| 07290018434000 | 3.5 x 8 |