ALIF Trial Caddy

GUDID 09348215045449

SIGNATURE ORTHOPAEDICS PTY LTD

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Primary Device ID	09348215045449
NIH Device Record Key	22ee1723-6038-43c7-927e-a63852aa9e31
Commercial Distribution Status	In Commercial Distribution
Brand Name	ALIF Trial Caddy
Version Model Number	W32-04-0301
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	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 Identifiers

Device Issuing Agency	Device ID
GS1	09348215045449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172019

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar