| Primary Device ID | 07506561200222 |
| NIH Device Record Key | f2c9f33b-3b5f-48c2-b3b3-651f5f73477e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INDALJIMTM |
| Version Model Number | BMD-L |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07506561200222 [Primary] |
| OEA | Non-Surgical Isolation Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-07 |
| Device Publish Date | 2022-01-28 |
| 07506561200277 | BE-01 |
| 07506561200260 | OV-XL |
| 07506561200253 | OV-L |
| 07506561200246 | OV-M |
| 07506561200239 | BMD-XL |
| 07506561200222 | BMD-L |
| 07506561200215 | BMD-M |
| 07506561200130 | C3C-01 |
| 07506561200062 | GR-01 |
| 07506561200055 | BS35-XL |
| 07506561200048 | BS35-L |
| 07506561200031 | BS35-M |
| 07506561200024 | BS25-XL |
| 07506561200017 | BS25-L |
| 07506561200000 | BS25-M |