| Primary Device ID | 00841277110869 |
| NIH Device Record Key | 7439171d-2cff-4be9-a0bb-a9de1170c599 |
| Commercial Distribution Discontinuation | 2025-12-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sempermed Syntegra Green |
| Version Model Number | SGR900 |
| Catalog Number | SGR900 |
| Company DUNS | 004072158 |
| Company Name | Harps USA, Inc. |
| Device Count | 50 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841277110869 [Unit of Use] |
| GS1 | 09001570536754 [Primary] |
| KGO | Surgeon'S Gloves |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2025-12-12 |
| 00841277110869 | Polyisoprene Surgical Glove PF - 9.0 |
| 00841277110852 | Polyisoprene Surgical Glove PF - 8.5 |
| 00841277110845 | Polyisoprene Surgical Glove PF - 8.0 |
| 00841277110838 | Polyisoprene Surgical Glove PF - 7.5 |
| 00841277110821 | Polyisoprene Surgical Glove PF - 7.0 |
| 00841277110814 | Polyisoprene Surgical Glove PF - 6.5 |
| 00841277110807 | Polyisoprene Surgical Glove PF - 6.0 |
| 00841277110791 | Polyisoprene Surgical Glove PF - 5.5 |