| Primary Device ID | 07506561200260 |
| NIH Device Record Key | dae307c8-ef2e-4730-999f-b01eff9e8e21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INDALJIMTM |
| Version Model Number | OV-XL |
| Company DUNS | 812753058 |
| Company Name | Indaljim, S.A. de C.V. |
| Device Count | 1 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |