| Primary Device ID | 00813172022356 |
| NIH Device Record Key | 496df5ee-8b55-44ee-b431-93be11c007f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prestige® Orthopaedic |
| Version Model Number | 131650 |
| Company DUNS | 802020693 |
| Company Name | INNOVATIVE HEALTHCARE CORPORATION |
| Device Count | 25 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813172022356 [Unit of Use] |
| GS1 | 10813172022353 [Primary] |
| GS1 | 20813172022350 [Package] Contains: 10813172022353 Package: 25 pr/bx, 4 bx/cs [4 Units] In Commercial Distribution |
| KGO | Surgeon'S Gloves |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-02-26 |
| Device Publish Date | 2022-12-08 |
| 00813172022356 | Gloves, Surgical, Latex, Powder-Free, Textured, Bisque Finish, 6.5 |
| 00813172022370 | Gloves, Surgical, Latex, Powder-Free, Textured, Bisque Finish, 7.5 |