| Primary Device ID | D811ACUFLOWMX2610 |
| NIH Device Record Key | f14f293f-5c98-45e8-98b5-96c3fff13509 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acu-Flow Temporary Matrix Material |
| Version Model Number | MX261 |
| Company DUNS | 206962040 |
| Company Name | Rainbow Specialty & Health Products Inc |
| 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 | false |
| 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 |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D811ACUFLOWMX2610 [Primary] |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-10 |
| D811TEMPMATRIXMX2610 | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance |
| D811ACUFLOWMX2610 | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance |