| Primary Device ID | 80726893510179 |
| NIH Device Record Key | 23583be6-2cc2-4fad-8636-fc83e1b6df22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | myONE S55 |
| Version Model Number | MYONE-S55-12 |
| Company DUNS | 364614362 |
| Company Name | GLOBAL PROTECTION CORP. |
| Device Count | 12 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00726893510173 [Primary] |
| GS1 | 00726893510869 [Primary] |
| GS1 | 80726893510179 [Unit of Use] |
| HIS | Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-11 |
| Device Publish Date | 2020-06-03 |
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