| Primary Device ID | 00851309000495 |
| NIH Device Record Key | 010a4fc9-1946-4b82-b08d-9089d4caa494 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Silk Nitrile Exam Gloves |
| Version Model Number | extra large |
| Catalog Number | GL96XL |
| Company DUNS | 148149243 |
| Company Name | NU RADIANCE INC |
| Device Count | 1 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com | |
| Phone | 920-337-0201 |
| info@sentrydental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851309000495 [Primary] |
| 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 | 2022-07-27 |
| Device Publish Date | 2022-07-19 |
| 00851309000495 | Blue Silk Nitrile Exam Gloves size extra large |
| 00851309000488 | Blue Silk Nitrile Exam Gloves size large |
| 00851309000471 | Blue Silk Nitrile Exam Gloves size medium |
| 00851309000464 | Blue Silk Nitrile Exam Gloves size small |
| 00851309000433 | Blue Silk Nitrile Exam Gloves size extra small |