| Primary Device ID | 00810147254699 |
| NIH Device Record Key | a3c06d9c-6f01-44ea-ac51-7624b27af46d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mastel Surgical |
| Version Model Number | ST-4 |
| Catalog Number | 80.ST-4 |
| Company DUNS | 197053028 |
| Company Name | INTERNATIONAL SURGICAL PRODUCTS INC |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810147254699 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-11 |
| Device Publish Date | 2025-02-03 |
| 00810147254712 | 10" L X 2.75" W PIN LOCK |
| 00810147254705 | 12" L X 2.75" W PIN LOCK |
| 00810147254699 | 4" L X 2.75" W PIN LOCK |
| 00810147254682 | 6" L X 2.75" W PIN LOCK |
| 00810147254675 | 8" L X 2.75" W PIN LOCK |
| 00810147254767 | INSTRUMENT TRAY ASSEMBLY 6.5 X 4 X .75 CONSISTS OF LID & SLOTTED BASE W/ 3-3/4" 5 SLOT KNIFE HOL |
| 00810147254750 | INSTRUMENT TRAY ASSEMBLY 10 X 6 X .75 CONSISTS OF LID, SLOTTED SHALLOW BASE, MAT |