LC Instrument Tray

GUDID 09348215039448

SIGNATURE ORTHOPAEDICS PTY LTD

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Primary Device ID	09348215039448
NIH Device Record Key	ad0e32be-90dc-4805-ab54-7cff09366a2e
Commercial Distribution Status	In Commercial Distribution
Brand Name	LC Instrument Tray
Version Model Number	112-152-122
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	09348215039448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153131

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer