| Primary Device ID | 10699320702526 | 
| NIH Device Record Key | 99b43b5b-17fc-4792-b064-38e6d47a608e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AMBITEX | 
| Version Model Number | VSM221 | 
| Catalog Number | VSM221 | 
| Company DUNS | 196027981 | 
| Company Name | Tradex International, Inc. | 
| Device Count | 100 | 
| 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 | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00699320702529 [Primary] | 
| GS1 | 10699320702526 [Package] Contains: 00699320702529 Package: CASE [10 Units] In Commercial Distribution | 
| GS1 | 30699320702520 [Unit of Use] | 
| LYZ | Vinyl 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 | 2019-04-12 | 
| Device Publish Date | 2019-04-04 | 
| 10699320702557 | AMBITEX STRETCH VINYL PF | 
| 10699320702540 | AMBITEX STRETCH VINYL PF LG | 
| 10699320702533 | AMBITEX STRETCH VINYL PF MD | 
| 10699320702526 | AMBITEX STRETCH VINYL PF SM | 
| 10699320202057 | AMBITEX VINYL PF XL | 
| 10699320202040 | AMBITEX VINYL PF LG | 
| 10699320202033 | AMBITEX VINYL MD PF | 
| 10699320202026 | AMBITEX VINYL PF SM | 
| 10699320107956 | AMBITEX LATEX EXAM PF XL | 
| 10699320107949 | AMBITEX LATEX EXAM PF LG | 
| 10699320107932 | AMBITEX LATEX EXAM PF MD | 
| 10699320107925 | AMBITEX LATEX EXAM PF SM | 
| 10699320107918 | AMBITEX LATEX EXAM PF XS | 
| 10699320102258 | AMBITEX LATEX HIGH RISK EXAM XL | 
| 10699320102241 | AMBITEX LATEX HIGH RISK EXAM PF LG | 
| 10699320102234 | AMBITEX LATEX HIGH RISK EXAM PF MD | 
| 10699320102227 | AMBITEX LATEX HIGH RISK EXAM SM | 
| 20699320452008 | NITRILE EXAM PF 10/12/10 FM | 
| 10699320102142 | AMBITEX LATEX EXAM GLV PF LG | 
| 00699320334706 | 33470-4 | 
| 10699320000196 | AMBITEX NITRILE EXAM GREEN PF SM 10/100 | 
| 10699320000233 | AMBITEX NITRILE EXAM GREEN PF XL 10/100 | 
| 10699320000158 | AMBITEX NITRILE EXAM GREEN PF MD 10/100 | 
| 10699320000073 | AMBITEX NITRILE EXAM GREEN PF LG 10/100 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AMBITEX  97412593  not registered Live/Pending | Bio Bolsa Ambitex Inc. 2022-05-16 | 
|  AMBITEX  77254577  3460873 Live/Registered | Tradex International, Inc. 2007-08-14 | 
|  AMBITEX  75037011  2015744 Live/Registered | Tradex International, Inc. 1995-12-26 |