OriginPlus Broach

GUDID 09348215081102

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach

Primary Device ID	09348215081102
NIH Device Record Key	1955bfb4-4581-48b4-9969-99a8cd7b2fcf
Commercial Distribution Status	In Commercial Distribution
Brand Name	OriginPlus Broach
Version Model Number	112-44-1016
Company DUNS	751993028
Company Name	SIGNATURE ORTHOPAEDICS PTY LTD
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	true
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 Identifiers

Device Issuing Agency	Device ID
GS1	09348215081102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201951

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument