| Primary Device ID | D105VP9007MI21 |
| NIH Device Record Key | d9371321-4b5d-40fb-87ad-877cbcbab175 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MacImpress |
| Version Model Number | VP-9007-MI |
| Company DUNS | 060635048 |
| Company Name | Surgimac LLC |
| Device Count | 4 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D105VP9007MI2 [Primary] |
| HIBCC | D105VP9007MI21 [Unit of Use] |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-03 |
| Device Publish Date | 2025-09-25 |
| D105VP9011MI21 | MacImpress VPS Impression Material Heavy Body, Fast Set, 50 ml Cartridges, 4/Pk |
| D105VP9011MI11 | MacImpress VPS Impression Material Heavy Body, Fast - 50 ml Cartridge |
| D105VP9007MI21 | MacImpress VPS Impression Material Heavy Body, Regular Set, 50 ml Cartridges, 4/Pk |
| D105VP9007MI11 | MacImpress VPS Impression Material Heavy Body, Regular - 50 ml Cartridge |