| Primary Device ID | 00098108000039 |
| NIH Device Record Key | 3e622418-8e2b-472c-a5b2-787559554172 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPLINTER OUT |
| Version Model Number | Splinter Out Kit - 28 |
| Company DUNS | 118797353 |
| Company Name | MediPoint Holdings LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00098108000039 [Primary] |
| LRR | First Aid Kit With Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-18 |
| Device Publish Date | 2025-07-10 |
| 00098108000008 | 19950 |
| 00098108000039 | Splinter Out Kit - 28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPLINTER OUT 74100326 1661601 Live/Registered |
MEDIPOINT, INC. 1990-09-24 |