| 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 |