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 |