SurgiMac
GUDID D1052115XS1000
Surgimac LLC
Nitrile examination/treatment glove, non-powdered, non-antimicrobial| Primary Device ID | D1052115XS1000 |
| NIH Device Record Key | e0552740-178d-4af7-872d-28522a0697e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiMac |
| Version Model Number | 2115XS-Case |
| Company DUNS | 060635048 |
| Company Name | Surgimac LLC |
| Device Count | 1000 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D1052115XS1000 [Unit of Use] |
| HIBCC | DXS2115CASE1000 [Primary] |
| HIBCC | DXSCASE2115 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| LZA | Polymer Patient Examination Glove |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-27 |
| Device Publish Date | 2023-06-19 |
On-Brand Devices [SurgiMac ]
Trademark Results [SurgiMac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGIMAC 90034986 not registered Live/Pending |
Waseem, Umair 2020-07-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.