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 |