| Primary Device ID | D105SKU104610 |
| NIH Device Record Key | a56157c5-f235-41c5-92f2-7f68884be83d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiMac |
| Version Model Number | 10-461 |
| Catalog Number | 10-461 |
| 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 | D105SKU104610 [Primary] |
| EFL | Forceps, Dressing, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-16 |
| Device Publish Date | 2024-05-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SURGIMAC 90034986 not registered Live/Pending |
Waseem, Umair 2020-07-03 |