Lapiplasty SpeedPlate

GUDID 00810111222587

Orthopaedic bone staple, non-adjustable

Primary Device ID	00810111222587
NIH Device Record Key	0d8fdd02-af46-4320-a843-1bff7bfe568c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Lapiplasty SpeedPlate
Version Model Number	SK54
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	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

Device Issuing Agency	Device ID
GS1	00810111222587 [Primary]

JDR	Staple, Fixation, Bone

Steralize Prior To Use	false
Device Is Sterile	true