| Primary Device ID | 00841277108798 |
| NIH Device Record Key | f6d9b7b7-d067-467d-b487-90a6fdb2c294 |
| Commercial Distribution Discontinuation | 2024-11-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | velvet XP 250 |
| Version Model Number | SMTN253 |
| Catalog Number | SMTN253 |
| Company DUNS | 004072158 |
| Company Name | SEMPERMED USA, INC. |
| Device Count | 250 |
| 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 | false |
| 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 |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841277108743 [Primary] |
| GS1 | 00841277108798 [Unit of Use] |
| 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 | 2024-11-25 |
| Device Publish Date | 2024-11-15 |
| 00841277108835 | velvet XP 250 Nitrile Exam Glove PF, sample pack |
| 00841277108811 | velvet XP 250 Nitrile Exam Glove PF, size XL |
| 00841277108804 | velvet XP 250 Nitrile Exam Glove PF, size L |
| 00841277108798 | velvet XP250 Nitrile Exam Glove PF, size M |
| 00841277108781 | velvet XP Nitrile Exam Glove PF, size S |
| 00841277108774 | velvet XP 250 Nitrile Exam Glove PF, size XS |