Primary Device ID | D105SKUMIR04CS1 |
NIH Device Record Key | 4b4c3cfc-95d1-4b29-b738-b98f867a3b5c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SurgiMac |
Version Model Number | MIR04-CS |
Catalog Number | MIR04-CS |
Company DUNS | 060635048 |
Company Name | Surgimac LLC |
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 | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
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 |
---|---|
HIBCC | D105SKUMIR04CS0 [Primary] |
HIBCC | D105SKUMIR04CS1 [Package] Contains: D105SKUMIR04CS0 Package: Case [100 Units] In Commercial Distribution |
EAX | Mirror, Mouth |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-26 |
Device Publish Date | 2024-04-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURGIMAC 90034986 not registered Live/Pending |
Waseem, Umair 2020-07-03 |