Primary Device ID | 00810111221740 |
NIH Device Record Key | 9bd6aeed-0fe5-469e-bd12-febfccfe816e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lapiplasty SpeedPlate |
Version Model Number | 02-00103 |
Company DUNS | 054808082 |
Company Name | Treace Medical Concepts, 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 | 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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810111221740 [Primary] |
JDR | Staple, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
[00810111221740]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-03 |
Device Publish Date | 2023-09-25 |
00810111221221 | Inserter Cap |
00810111220798 | Rapid Compression Implants |
00810111221382 | Rapid Compression Implants |
00810111221214 | Inserter Cap |
00810111220637 | Inserter Rod |
00810111220620 | Inserter Rod |
00810111220804 | Rapid Compression Implants |
00810111221672 | Rapid Compression Implants |
00810111222105 | Threaded Rods |
00810111222099 | Threaded Rods |
00810111221788 | Rapid Compression Implants |
00810111221771 | Rapid Compression Implants |
00810111221764 | Rapid Compression Implants |
00810111221757 | Inserter Cap |
00810111221740 | Inserter Cap |
00810111222303 | Instrument Tray |
00810111222396 | Rapid Compression Implants |
00810111222600 | Inserter Rod |
00810111222594 | Inserter Cap |
00810111222587 | Rapid Compression Implants |
00810111220293 | Inserter Cap |
00810111223607 | Micro-Quad™ Inserter Cap 15.5MM |