| Primary Device ID | 00810633021651 |
| NIH Device Record Key | 1d685c47-fd3a-4a06-b0ee-178a59d00c41 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Speed Triad |
| Version Model Number | DK-200T |
| Company DUNS | 792619009 |
| Company Name | Biomedical Enterprises, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810633021651 [Primary] |
| KDD | Kit, Surgical Instrument, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-07 |
| Device Publish Date | 2015-10-24 |
| 00810633021668 | Speed Triad Implant Sizing Guide |
| 00810633021651 | Speed Triad Drill Kit |
| 00810633021644 | Speed Triad 20X15X08mm 3 Legs, centered |
| 00810633021637 | Speed Triad 20X15X08mm 3 Legs, right offset |
| 00810633021620 | Speed Triad 20X15X08mm 3 Legs, left offset |
| 00810633021613 | Speed Triad 18X15X08mm 3 Legs, centered |
| 00810633021606 | Speed Triad 18X15X08mm 3 Legs, right offset |
| 00810633021590 | Speed Triad 18X15X08mm 3 Legs, left offset |