Primary Device ID | TD1054116L100 |
NIH Device Record Key | f49dd7f7-db0c-480d-b8f9-2091571e4a08 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SurgiMac |
Version Model Number | T4116-L |
Company DUNS | 060635048 |
Company Name | Surgimac LLC |
Device Count | 100 |
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 | TD1054116L100 [Unit of Use] |
HIBCC | TDL4116100 [Primary] |
LZA | Polymer Patient Examination Glove |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-22 |
Device Publish Date | 2023-12-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURGIMAC 90034986 not registered Live/Pending |
Waseem, Umair 2020-07-03 |