| Primary Device ID | 50810572003546 |
| NIH Device Record Key | e7054518-51c0-47b6-ab8c-7916780f2312 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmniTrush |
| Version Model Number | 201-220 |
| Catalog Number | 201-220 |
| Company DUNS | 079434709 |
| Company Name | OMNI INTERNATIONAL CORP. |
| Device Count | 200 |
| 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 | true |
| 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 | false |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com | |
| Phone | 603-471-1499 |
| info@omnigloves.com |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810572003541 [Primary] |
| GS1 | 10810572003548 [Unit of Use] |
| GS1 | 50810572003546 [Package] Contains: 00810572003541 Package: Shipper Carton [10 Units] In Commercial Distribution |
| LZA | Polymer Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-10 |
| Device Publish Date | 2025-01-31 |
| 50810572002211 - OmniTrust | 2025-05-23 OmniTrust Vinyl Examination Gloves, Small |
| 10810572002220 - OmniTrust | 2025-05-23 OmniTrust Vinyl Examination Gloves, Medium |
| 50810572002235 - OmniTrust | 2025-05-23 OmniTrust Vinyl Examination Gloves, Large |
| 50810572002242 - OmniTrust | 2025-05-23 OmniTrust Vinyl Examination Gloves, X-Large |
| 50810572000439 - OmniTrust | 2025-02-10 Nitrile Examination Glove Powder Free XX-Large |
| 50810572003485 - OmniTrust | 2025-02-10 Nitrile Examination Glove Powder Free X-Small |
| 50810572003539 - OmniTrust | 2025-02-10 Nitrile Examination Glove Powder Free XX-Large |
| 50810572003546 - OmniTrush | 2025-02-10Nitrile Examination Glove Powder Free X-Small |
| 50810572003546 - OmniTrush | 2025-02-10 Nitrile Examination Glove Powder Free X-Small |