| Primary Device ID | 10841277105916 |
| NIH Device Record Key | d1a6abb2-f9bf-4a8c-a2f6-865115b65b6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sempermed Syntegra IR Polyisoprene Surgical Glove |
| Version Model Number | SIR600 |
| Catalog Number | SIR600 |
| Company DUNS | 004072158 |
| Company Name | SEMPERMED USA, INC. |
| Device Count | 50 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
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