| Primary Device ID | 10813172020502 |
| NIH Device Record Key | fd6c640b-b3ad-498f-91d1-2a3c61f138c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NitriDerm® Ultra Orange™ |
| Version Model Number | 199400 |
| Company DUNS | 802020693 |
| Company Name | INNOVATIVE HEALTHCARE CORPORATION |
| Device Count | 80 |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813172020505 [Unit of Use] |
| GS1 | 10813172020502 [Package] Contains: 20813172020509 Package: 80/bx, 10 bx/cs [10 Units] In Commercial Distribution |
| GS1 | 20813172020509 [Primary] |
| LZA | Polymer Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-05-21 |
| Device Publish Date | 2022-12-08 |
| 10813172020519 | Gloves, Exam, Nitrile, Non-Sterile,Powder-Free, Textured, Orange, XXXL |
| 10813172020502 | Gloves, Exam, Nitrile, Non-Sterile,Powder-Free, Textured, Orange, XXL |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NITRIDERM 75645079 2449807 Live/Registered |
Innovative Healthcare Supply, Inc. 1999-02-23 |