restor3d Kinos Axiom Instrumentation

GUDID 00840097507484

Talar Peg Drill, Non-Sterile

Restor3d

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Primary Device ID	00840097507484
NIH Device Record Key	c6b88440-e573-406f-9c0b-afef0b013b61
Commercial Distribution Status	In Commercial Distribution
Brand Name	restor3d Kinos Axiom Instrumentation
Version Model Number	5801-0045
Company DUNS	080819836
Company Name	Restor3d
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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097507484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192778

FDA Product Code

HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer