| Primary Device ID | 10054003788585 |
| NIH Device Record Key | 9f8d2bac-ea96-49af-b5bb-19d18575447f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Union |
| Version Model Number | Union Latex Condoms MAX |
| Catalog Number | 11402 |
| Company DUNS | 175425982 |
| Company Name | MAYER LABORATORIES, INC. |
| Device Count | 144 |
| 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 | 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 |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Length | 160 Millimeter |
| Width | 60 Millimeter |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00054003788588 [Primary] |
| GS1 | 10054003788585 [Package] Contains: 20054003788582 Package: MASTER CARTON [20 Units] In Commercial Distribution |
| GS1 | 20054003788582 [Package] Contains: 00054003788588 Package: CARTON [144 Units] In Commercial Distribution |
| GS1 | 30054003788589 [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 | 2023-11-14 |
| Device Publish Date | 2023-11-06 |
| 20054003788605 | Latex Condoms 144 ct |
| 10054003788592 | Latex Condoms 144 ct |
| 10054003788585 | Latex Condoms 144 ct |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNION 97899379 not registered Live/Pending |
THE HUMAN UNION, LLC 2023-04-20 |
![]() UNION 97899379 not registered Live/Pending |
Smeltzer, Michael 2023-04-20 |
![]() UNION 97873897 not registered Live/Pending |
Union Uhrenfabrik GmbH 2023-04-05 |
![]() UNION 97863500 not registered Live/Pending |
The Union LLC 2023-03-29 |
![]() UNION 97862800 not registered Live/Pending |
The Union LLC 2023-03-29 |
![]() UNION 97730181 not registered Live/Pending |
Union Uhrenfabrik GmbH 2022-12-23 |
![]() UNION 97697560 not registered Live/Pending |
WireCo WorldGroup Inc. 2022-11-30 |
![]() UNION 97569173 not registered Live/Pending |
Union Credit Inc. 2022-08-29 |
![]() UNION 97432208 not registered Live/Pending |
Pool Data Ltd 2022-05-27 |
![]() UNION 97379136 not registered Live/Pending |
Major League Soccer, L.L.C. 2022-04-25 |
![]() UNION 90832644 not registered Live/Pending |
Monterey Bay Football Club LLC 2021-07-16 |
![]() UNION 90531550 not registered Live/Pending |
Nuclyde Inc. 2021-02-17 |