| Primary Device ID | 00726893510005 |
| NIH Device Record Key | b00ce35f-821d-4974-90bc-0ececc00ada1 |
| Commercial Distribution Discontinuation | 2022-01-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | myONE E55 |
| Version Model Number | MYONE-E55-6 |
| Company DUNS | 364614362 |
| Company Name | GLOBAL PROTECTION CORP. |
| Device Count | 6 |
| 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 | false |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00726893510005 [Primary] |
| GS1 | 80726893510001 [Unit of Use] |
| HIS | Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-03-28 |
| Device Publish Date | 2020-06-01 |
| 80726893510001 | 12 Lubricated Male Latex Condoms |
| 00726893510005 | 6 Lubricated Male Latex Condoms |